Diagnostica Stago, Inc. Product Catalog 2016 - 3c
Transcription
Diagnostica Stago, Inc. Product Catalog 2016 - 3c
Diagnostica Stago, Inc. Product Catalog 2016 STA® Family of Hemostasis Analyzers The STA® Family of Hemostasis Analyzers provides automation of coagulation testing for a variety of laboratory situations. Each system performs clotting, chromogenic and immunoassay methodologies in random access mode. Because all STA® analyzers use the same analysis methods and the same reagent formulations, they offer standardization in the laboratory. MODELS: AUTOMATED STA R Max®: Automation capable, high throughput STA Compact Max®: Moderate throughput STA Satellite®: Low throughput MODELS: SEMI-AUTOMATED STart® FEATURES Host-query bi-directional interface Primary tube sampling Continuous sample access Open reagent system Reagent and disposable management Reagent level detection QC management with Levy-Jennings Reagent and sample bar code reader Auto re-run and auto re-dilute options Programmable and pre-programmed options Up to 70 on-board reagent capacity Capacity of up to 1,000 disposable cuvettes Multi-constituent controls and calibrator METHODOLOGIES Clotting - VDS™ Mechanical Clot Detection Chromogenic - Optical density Immunological - Optical density STA® ASSAY MENU PT APTT Fibrinogen (Clauss) D-dimer (Quantitative) Thrombin Time Reptilase Time Extrinsic Factors Intrinsic Factors Anti-Xa Activity Unfractionated Heparin (UFH) Low Molecular Weight Heparin (LMWH) Rivaroxaban* Apixaban* Edoxaban* Ecarin Chromogenic Assay (ECA-II)* Dabigatran* Antithrombin (AT) Activity Antithrombin (AT) Antigen Protein C Activity (clot-based and chromogenic) Protein S Activity Free Protein S Antigen Total Protein S Antigen VWF Antigen Plasminogen Activity Antiplasmin Activity Fibrin Monomer* Lupus Anticoagulants DRVVT (Screen and Confirm) PTT-LA Staclot LA *(research use only; not for use in diagnostic procedures) 2 Product Catalog 2016 Table of Contents Section 1 Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Section 2 Disposables & Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Section 3 Screening Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Section 4 Factor Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Section 5 Anticoagulants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Section 6 Thrombophilia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Section 7 Fibrin Formation & Degradation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Section 8 Fibrinolysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Section 9 Primary Hemostasis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Section 10 Control Plasmas. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Section 11 Calibrators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Section 12 Auxiliary Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Section 13 Quality & Compliance Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Section 14 Stago Added Value on Request (SAVOR™). . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Section 15 Thrombin Generation Research Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Section 16 Ecarin Chromogenic Assay (ECA) Products . . . . . . . . . . . . . . . . . . . . . . . . . 25 Section 17 Flow Cytometry Research Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Section 18 Research Kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Section 19 Research Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Terms & Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Main Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37-38 For the most up-to-date information on all our products, contact the Diagnostica Stago, Inc. Marketing Dept. at 800-222-COAG or visit our website at www.stago-us.com. PRODUCT AVAILABILITY: Most clinical reagents are available within 5 days after receipt of order. However if a sequestered lot of reagent is required, please contact Sales Administration for availability. For availability of research products, please contact Sales Administration at 800-222-COAG, option 3. Research products not in stock may require a 60-day notice prior to availability. 1 Instruments (continued) Section 1 CAT. NO. PRODUCT/ DESCRIPTION 59010 STA R Max® Hemostasis System with Cap Piercing 59013 STA R Max® Hemostasis System Fully Automated, High-Throughput Hemostasis Analyzer (Automation-Capable) Fully Automated, High-Throughput Hemostasis Analyzer (Automation-Capable) The newest member of the Max Generation family of hemostasis analyzers, the STA R Max® is a high-volume, high-efficiency analyzer that embodies Stago’s standardization of methodology, software, reagents, and consumables. Built on the most reliable platform in the industry with an expansive test menu, the STA R Max® is the perfect hemostasis partner for high-volume and reference laboratories performing routine and specialty assays. Interference free Viscosity-based Detection System (VDS), exclusive to Stago, is at the heart of the STA R Max® providing maximum sensitivity for weak clot detection and insensitivity to interferences ensuring reliability of results. The STA R Max® enhances efficiency with features including the largest sample capacity in the industry and true STAT sample priority. Optimized random access test management provides maximum throughput for routine and specialty coagulation testing. With the most TLA connections worldwide, the STA-R® family of analyzers is the industry leader for total laboratory automation (TLA) connectivity and throughput. STA Coag Expert® software integrates over fifty years of Stago coagulation expertise into every STA R Max® system. The STA Coag Expert® automates laboratory processes such as multi-dilution factor assays, automatic reflex testing, automatic repeats and delta checks to ensure standardization and efficiency for routine tests as well as complex specialty assays. Integrated accreditation tools, automated maintenance logs, integrated video tutorials and five years of patient and QC archives stored onboard ensure industry leading tools for regulatory compliance. The STA R Max® with STA Coag Expert® equips laboratories with an easy to use system that ensures efficient, reliable results the first time, every time. Analyzer is provided with: 22 inch LCD touch screen flat panel monitor USB handheld barcode reader STA R Max® Computer Table STA Coag Expert® Pack RJ45 straight Ethernet cable 10M Max Generation mouse pad Dimensions • Height . . . . . 49.8 inches • Width . . . . . 48.0 inches Uninterruptible power supply Operator’s reference manual Accessory kit 1-year warranty Brother printer (optional) • Depth . . . . . 31.6 inches • Weight . . . . 524.7 pounds Test Selections 200 user definable tests Samples • 215 sample tubes on board • 15 sample racks/75 samples • Continuous loading and unloading of sample racks • True STAT capability • Primary tube sizes accepted including pediatrics & microcontainers • Barcode identification/Positive patient ID • Automatic pre-dilution and dilution of samples LIS Interface Bi-directional host-query Automation Compatible with all major automation line solutions Reagent Menu • 70 reagent positions capable of performing a complete range of routine and specialty tests. Contact your Stago Representative for the most current listing. • Random loading of reagents • Positive barcode identification • Temperature controlled • Precalibration for many reagents • Automatic pre-dilution of calibrators • Automatic Quality Control STA R Max® 3 Section 1 Instruments (continued) CAT. NO. PRODUCT/ DESCRIPTION 58990 STA Compact Max® Coagulation System 58989 STA Compact Max® Coagulation System Cap Piercing Model Fully Automated, Moderate-Throughput Hemostasis Analyzer Fully Automated, Moderate-Throughput Hemostasis Analyzer The STA Compact Max® is a fully automated, bench top hemostasis workstation capable of performing clotting, chromogenic and immunological assays simultaneously in random access mode. The system’s unique method of sample management offers moderate throughput and rapid processing of STAT samples with no impact on the instrument’s performance. All sample and calibrator dilutions are performed automatically, increasing staff productivity for laboratories performing moderate-volume routine and specialty coagulation testing. The STA Compact Max® takes innovation to the next level by adding the state of the art STA Coag Expert® software. The STA Coag Expert® automates laboratory processes such as multi-dilution factor assays, automatic reflex testing, automatic repeats and delta checks to ensure standardization and efficiency for the complete analyzer testing profile. Integrated accreditation tools, automated maintenance logs, integrated video tutorials and five years of patient and QC archives stored onboard ensure industry leading tools for regulatory compliance. The combination of VDS methodology and the STA Coag Expert® on the STA Compact Max® give you complete confidence in your results - the most important part of any analyzer. Analyzer is provided with: • STA Coag Expert® Pack • 22-inch LCD touch screen flat panel monitor • Uninterruptible power supply • Max Generation mouse pad • Operator’s reference manual • Accessory kit • 1-year warranty • Brother printer (optional) Dimensions • Height . . . . • Width . . . . . • Depth . . . . . • Weight . . . . 27.75 inches 38.1 inches 28.73 inches 309 pounds Test Selections 80 user-definable tests Samples • 96 sample tubes onboard (84 primary tube positions; 12 pediatric tube positions) • All common tube sizes accepted including pediatrics & microcontainers • Random loading of samples • True STAT management • New 4th generation cap piercing option • Barcode identification/Positive patient ID • Automatic pre-dilution and dilution of samples LIS Interface Bi-directional host-query or dynamic download Reagent Menu • 45 reagent positions, supporting multiple vial sizes, capable of performing most routine and specialty tests. Contact your Stago Representative for the most current listing. • Random loading of reagents • Positive barcode identification • Temperature controlled • Pre-calibration for all routine tests • Automatic pre-dilution of calibrators • Automatic Quality Control 4 Product Catalog 2016 STA Compact Max® Instruments (continued) CAT. NO. PRODUCT/ DESCRIPTION 58104 STA Satellite® Hemostasis System Section 1 Fully Automated, Low-Throughput Hemostasis Analyzer The STA Satellite® is a fully automated benchtop hemostasis analyzer capable of performing clotting, chromogenic and immunological assays simultaneously in random access mode. The system enables lntegrated Health Networks to standardize patient testing results including D-dimer and Anti-Xa. Thanks to its technological innovations, STA Satellite® ensures a high reliability level as well as ease of use, flexibility and complete security, all within a reduced footprint. Analyzer is provided with: • Accessory Kit • Operator’s reference manual • 1-year warranty Dimensions • Height . . . . • Width . . . . • Depth . . . . • Weight . . . 27.4 inches 21.1 inches 25.5 inches 72 pounds Test Selections 80 user definable tests Samples • 20 onboard sample capacity • Primary tube sampling • Removable sample carousel • Continous sample loading • Positive sample identification LIS Interface Bi-directional host-query Other Features • LED for chromogenic assays • Internal barcode reader for samples and reagents • Stago’s exclusive method of VDSTM Mechanical Clot Detection (Viscosity-based Detection System) technology Reagent Menu • PT • APTT • Fibrinogen • AT • Liquid Anti-Xa (UFH and LMWH) • D-dimer STA Satellite® 5 Section 1 Instruments (continued) CAT. NO. PRODUCT/ DESCRIPTION 58230 STart® Hemostasis Analyzer Benchtop Hemostasis Analyzer for Batch Testing The STart® is a benchtop hemostasis analyzer featuring Stago’s exclusive method of VDS™ Mechanical Clot Detection (Viscosity-based Detection System). This method eliminates interference from lipemic, icteric or other optically dense samples or reagents. The analyzer offers programmable and pre-programmed assays with curve storage, 4 independently-timed incubation stations, electronically-linked multiple pipettor, 40-character liquid crystal display and an internal thermal printer. Its lightweight, compact size makes it ideal for low to medium volume batch testing or as a back-up to an optical clot detection system. Analyzer is provided with: • Accessory kit • Cabled pipette • Operator’s reference manual • 1-year warranty Dimensions • Height . . . . • Width . . . . . • Depth . . . . . • Weight . . . . 4.7 inches 16.1 inches 16.5 inches 12.5 pounds Methodology Clotting - Standard VDSTM Mechanical Clot Detection Test Selections • 17 test selections • Preprogrammed and programmable options Other Features • Electronically-linked multiple pipettor for convenience and accuracy • Integrated printer • Four independently-timed incubation stations with audible signal • Lightweight and compact Reagent Menu • PT • APTT • Fibrinogen • Thrombin Time • Reptilase Time • Extrinsic Factors • Intrinsic Factors • Protein C Activity • Protein S Activity • PTT-LA • Staclot® LA (Lupus Anticoagulants) • DRVV STart® 6 Product Catalog 2016 Disposables & Accessories CAT. NO. PRODUCT/ DESCRIPTION Section 2 CONTENTS STA-R® Family, STA Compact® and STA Satellite® Disposables & Accessories 00741 STA®-Microtainers (for samples) 500 each 00797 STA®-Mini Reducer (5 mL vials) 100 each 00801 STA®-Maxi Reducer (10 and 15 mL vials) 100 each 00802 STA®-Microcups (for reagents) 100 each 26538 STA -Colorimetry Box Filter (metal frame) 1 each 26555 Magnetic Ball Extractor 1 each 26674 Magnetic Red Stir Bar (C.K. Prest Only) 1 each 26699 Halogen Lamp 1 each 27307 Needle # 3 1 each 27354 Needle # 2 1 each (STA Compact®) 27420 Rear Panel Air Filters 2 each (STA Compact®) 27423 Sample Microtainer Adapter (tall) 2 each (STA Compact®) 27425 Magnetic White Stir Bar 1 each 27457 Rinsing Plate Assay Air Filter (paper filter) 1 each (STA Compact®) 27458 Liquid Filter 1 each 27530 Teflon Syringe Tip and O-Ring Kit Pack 6 each 27538 Hamilton Syringe 1 each 27543 Reduction Ring for Microcups 2 each 38125 Optical Module Fan Filter 1 each 38517 Air Filter 1 each (STA-R®) 38581 Tubing, Cap Piercing Electrovalve 1 each (STA Compact®) 38640 Liquid Cooling Glycol (Peltier System) 1 liter 38646 Needle #1 1 each (STA Compact®) 38669 STA®-Cuvettes 6 x 1000 (STA Compact® & STA-R®) 38960 STA-R® Shuttle 1 each 39002 Aluminum Microtainer Adapters 10 each (STA-R®) 39010 Tray for 15 Racks 2 each 39011 Mapping Adjustment Cuvette 1 each 39022 Needle # 1 Cap Piercing 1 each (STA Compact®) 39134 Wheel Tube Rotation 1 each 39164 Needle # 1 Cap Piercing 1 each (STA-R®) 39249 Needle # 1 1 each (STA-R®) 39250 Needle # 2 1 each (STA-R®) 88349 V2 (Pediatric Racks) Set of 2 (STA-R®) ® 7 Section 2 CAT. NO. Disposables & Accessories (continued) PRODUCT/ DESCRIPTION CONTENTS STA-R® Family, STA Compact® and STA Satellite® Disposables & Accessories (continued) 39356 Sample Needle 1 each (STA Satellite®) 39430 STA Satellite® Cuvettes 6 x 220 (STA Satellite®) 39968 Microcup Adapter 2 each (STA Satellite®) 80057 Microtainer Reducer 2 each (STA Satellite®) 80132 Air Filters 3 each (STA Satellite®) 80203 Microtainer Rack 2 each (STA-R®) 80343 Soft Stylet Pack of 10 88828 Reducer DIN 14 2 each (STA Satellite®) STart® Disposables & Accessories 26405 Magnetic Stir Bars (white triangular) 1 each 26441 Ball Vial (1850 / vial) 1 each 26555 Ball Extractor 1 each 26649 Thermal Paper 1 each 26729 5 mL Reduction Ring 1 each 38876 STart® Cuvettes (4 x 150) 600 / box 39476 Ball Dispenser 1 each 80109 Finnpipette 1 each 80600 Finn Tips 1.25 mL (Finnpipette Only) 100 / box 80601 Finn Tips 2.5 mL (Finnpipette Only) 100 / box 80602 Combi Tips 1.25 mL (Eppendorf Only) 100 / box 80603 Combi Tips 2.5 mL (Eppendorf Only) 100 / box Miscellaneous Parts 8 26605 Reduction Ring DIN 14 (1.0 to 10 mL) 2 each 26610 Reagent Vial Reduction Ring DIN 18 (5.0 to 10 mL) 2 each 26681 Fuse 6.3 Amp Pack of 10 (STA Satellite®) 26694 Fuse 15 Amp Pack of 10 27037 Fuse 4.0 Amp Pack of 10 27575 Fuse 6.25 Amp Pack of 10 27576 Fuse 2.0 Amp Pack of 10 27578 Fuse 5.0 Amp Pack of 10 27579 Fuse 1.0 Amp Pack of 10 27581 Fuse 3.0 Amp Pack of 10 Product Catalog 2016 Section 3 Screening Tests CAT. NO. PRODUCT/ DESCRIPTION 00605* STA®-Neoplastine® CI 5 CONTENTS Determination of Prothrombin Time (PT) by STA analyzers (ISI~1.8). Freeze-dried rabbit brain thromboplastin with heparin inhibitor. ® 00606* STA®-Neoplastine® CI Plus 5 Determination of Prothrombin Time (PT) by STA® analyzers (ISI~1.3). Freeze-dried rabbit brain thromboplastin with heparin inhibitor. 00667US* STA®-Neoplastine® CI Plus 10 Determination of Prothrombin Time (PT) by STA analyzers (ISI~1.3). Freeze-dried rabbit brain thromboplastin with heparin inhibitor. ® 00595US 6 x 5 mL vials of STA® Neoplastine® CI 5 6 x 5 mL vials of Solvent 6 x 5 mL vials of STA® Neoplastine® CI Plus 5 6 x 5 mL vials of Solvent 12 x 10 mL vials of STA® Neoplastine® CI Plus 10 12 x 10 mL vials of Solvent STA®-PTT Automate 5 12 x 5 mL vials STA®-C.K. Prest® 5 6 x 5 mL vials of STA® C.K. Prest® 5 6 x 5 mL vials of Activator STA®-Fibrinogen 5 12 x 5 mL vials STA®-Thrombin 2 12 x 2 mL vials STA®-Thrombin 10 12 x 10 mL vials STA®-Reptilase® 6 x 2 mL vials Determination of Activated Partial Thromboplastin Time (APTT) by STA® analyzers. Cephalin reagent with particulate (silica) activator. 00597 Determination of Activated Partial Thromboplastin Time (APTT) by STA® analyzers. Cephalin reagent with kaolin activator. 00674US Quantitative determination of Fibrinogen by STA® analyzers (Clauss Method). Freeze-dried human thrombin (~80 NIH units/mL) with heparin inhibitor and calcium. 00611 Determination of Thrombin Time by STA® analyzers. Freeze-dried human thrombin (1.5 NIH units/mL) with calcium. 00669 Determination of Thrombin Time by STA® analyzers. Freeze-dried human thrombin (1.5 NIH units/mL) with calcium. 00614 Determination of Reptilase® Time. Extracted venom of Bothrops atrox, ~20 BU (Batroxobin unit) per vial. * ISI values for PT reagents are approximations. Actual ISI values are assigned for each lot of PT reagent. 10 Product Catalog 2016 Factor Assays Section 4 CAT. NO. PRODUCT/ DESCRIPTION CONTENTS 00722 STA -Deficient XII 6 x 1 mL vials STA®-Deficient XI 6 x 1 mL vials STA®-Deficient IX 6 x 1 mL vials STA®-Deficient VIII 6 x 1 mL vials STA®-Deficient X 6 x 1 mL vials STA®-Deficient VII 6 x 1 mL vials STA®-Deficient V 6 x 1 mL vials STA®-Deficient II 6 x 1 mL vials Asserachrom® IX:Ag 3 x 2 Coated Strips 3 x 8 mL vials of Anti-IX:Ag-Peroxidase 3 x 8 mL vials of TMB 3 x 50 mL bottles of Dilution Buffer 1 x 50 mL bottle of Washing Solution 3 x 0.5 mL vials of F. IX:Ag Calibrator 3 x 0.5 mL vials of F. IX:Ag Control 1 Plate Frame; 1 Plate Cover ® Substrate plasma for Factor XII assay by STA® analyzers. Freeze-dried human plasma lacking Factor XII. 00723 Substrate plasma for Factor XI assay by STA® analyzers. Freeze-dried human plasma lacking Factor XI. 00724 Substrate plasma for Factor IX assay by STA® analyzers. Freeze-dried human plasma from which Factor IX has been removed by selective immuno-adsorption. 00725 Substrate plasma for Factor VIII assay by STA® analyzers. Freeze-dried human plasma from which Factor VIII has been removed by selective immuno-adsorption. 00738 Substrate plasma for Factor X assay by STA® analyzers. Freeze-dried human plasma from which Factor X has been removed by selective immuno-adsorption. 00743 Substrate plasma for Factor VII assay by STA® analyzers. Freeze-dried human plasma from which Factor VII has been removed by selective immuno-adsorption. 00744 Substrate plasma for Factor V assay by STA® analyzers. Freeze-dried human plasma, artificially depleted of Factor V. 00745 Substrate plasma for Factor II assay by STA® analyzers. Freeze-dried human serum and absorbed bovine plasma, the latter providing Factor V and fibrinogen to the test system. 00943 Enzyme immunoassay of Factor IX Antigen by ELISA method, 96 tests. 11 Section 5 CAT. NO. Anticoagulants PRODUCT/ DESCRIPTION CONTENTS Heparin Anti-Xa Chromogenic Assays 00311US STA®-Liquid Anti-Xa 4 6 x 4 mL vials of Reagent 1 (Substrate) 6 x 4 mL vials of Reagent 2 (F.Xa) STA®-Liquid Anti-Xa 8 6 x 8 mL vials of Reagent 1 (Substrate) 6 x 8 mL vials of Reagent 2 (F.Xa) Chromogenic assay for the quantitative determination of unfractionated (UFH) and low molecular weight heparins (LMWH) in plasma by measuring anti-Xa activity on antithrombin in a competitive assay by STA® analyzers. 00322US Chromogenic assay for the quantitative determination of unfractionated (UFH) and low molecular weight heparins (LMWH) in plasma by measuring anti-Xa activity on antithrombin in a competitive assay by STA® analyzers. 00906 4 x 2 mL vials of AT III Chromogenic assay of unfractionated and low molecular weight heparins. 2 x 15 mL vials of Buffer 4 x 4 mL vials of F. Xa Lyophilized chromogenic substrate CBS 31.39, purified bovine AT III, 4 x 4 mL vials of Substrate purified bovine Factor Xa, Tris buffer. Stachrom® Heparin Heparin Induced Thrombocytopenia (HIT) 00615 Asserachrom® HPIA (ELISA) Determination of anti-heparin - PF4 antibodies by ELISA method, 48 tests. Section 6 CAT. NO. 3 x 2 Coated Strips 6 x 2 mL vials of Anti-lgG,A,M-Peroxidase 6 x 8 mL vials of TMB 3 x 30 mL bottles of Dilution Buffer 1 x 50 mL bottle of Washing Solution 3 x 1 mL vials of HPIA Reference 3 x 1 mL vials of Control 1 3 x 1 mL vials of Control 2 1 Plate Frame; 1 Plate Cover Thrombophilia PRODUCT/ DESCRIPTION CONTENTS STA®-Liatest® Free Protein S 6 x 6 mL vials of Latex 6 x 5 mL vials of Buffer Liatest® AT III 6 x 1 mL vials of Latex 6 x 4 mL vials of Buffer lnhibitors 00516 lmmuno-turbidimetric assay for Free Protein S Antigen by STA® analyzers. Suspension of microparticles coated with monoclonal antibodies to Free Protein S. 00568 lmmuno-turbidimetric assay for Antithrombin Antigen. Suspension of microlatex particles coated with rabbit anti-human AT antibodies. 00570 12 6 x 1 mL vials of Latex 6 x 4 mL vials of Buffer lmmuno-turbidimetric assay for Total Protein S Antigen. Suspension of microlatex partlcles coated with rabbit anti-human total protein S antibodies. Liatest® Protein S Product Catalog 2016 Thrombophilia (continued) Section 6 CAT. NO. PRODUCT/ DESCRIPTION CONTENTS 00596 STA -Stachrom AT III 4 x 3 mL vials of Thrombin 4 x 3 mL vials of Substrate 4 x 3 mL vials of Thrombin Solvent STA®-Stachrom® Protein C 6 x 3 mL vials of PC-Actlvator 6 x 3 mL vials of Substrate STA®-Staclot® Protein S 2 x 1 mL vials of Protein S Deficient Plasma 2 x 1 mL vials of PCa 2 x 1 mL vials of F.Va STA®-Staclot® Protein C 3 x 1 mL vials of Protein C Deficient Plasma 3 x 1 mL vials of PC-Activator Asserachrom® Protein C 3 x 2 Coated Strips 3 x 8 mL vials of Anti-Protein C-Peroxidase 3 x 8 mL vials of TMB 3 x 50 mL bottles of Dilution Buffer 1 x 50 mL bottles of Washing Solution 3 x 0.5 mL bottles of Protein C Calibrator 3 x 0.5 mL bottles of Protein C Control 1 Plate Frame; 1 Plate Cover Asserachrom® Total Protein S 3 x 2 Coated Strips 3 x 2 mL vials of Anti-Total PS-Peroxidase 3 x 8 mL vials of TMB 3 x 50 mL bottles of Dilution Buffer 1 x 50 mL bottles of Washing Solution 3 x 0.5 mL bottles of Total Protein S Calibrator 3 x 0.5 mL bottles of Total Protein S Control 1 Plate Frame; 1 Plate Cover Asserachrom® Free Protein S 3 x 2 Coated Strips 3 x 2 mL vials of Anti-Free PS-Peroxidase 3 x 8 mL vials of TMB 3 x 50 mL bottles of Dilution Buffer 1 x 50 mL bottles of Washing Solution 3 x 0.5 mL bottles of Free Protein S Calibrator 3 x 0.5 mL bottles of Free Protein S Control 1 Plate Frame; 1 Plate Cover ® ® Chromogenic assay of Antithrombin activity by STA® analyzers. Bovine thrombin ~ 11.3 nKat/mL, freeze-dried. 00671 Chromogenic assay for the quantitative determination of functional Protein C by STA® analyzers. Highly purified extract of Agkistrodon c. contortrix venom for specific activation of Protein C with chromogenic substrate CBS 42.46 of ~15 μmoles/vial. 00746 Clotting assay for the quantitative measurement of the functional Protein S level based on the principal of Factor Va inhibition by STA® analyzers. Lyophilized human plasma, human activated Protein C; bovine Va; free of Protein S. 00747 Clotting assay of Protein C activity of STA® analyzers. Lyophilized human plasma free of Protein C; highly purified extract of Agkistrodon c. contortrix venom for specific activation of Protein C. Freeze-dried with an activator selected specially for Protein C assay. 00944 Enzyme lmmunoassay for Protein C Antigen by ELISA method, 96 tests. 00945 Enzyme immunoassay for Total Protein S Antigen by ELISA Method, 96 tests. 00946 Enzyme immunoassay for Free Protein S Antigen by ELISA Method, 96 tests. 13 Section 6 CAT. NO. Thrombophilia (continued) PRODUCT/ DESCRIPTION CONTENTS Lupus Anticoagulants 00339 STA®-Staclot® DRVV Screen 2 12 x 2 mL vials STA®-Staclot® DRVV Screen 5 12 x 5 mL vials STA®-Staclot® DRVV Confirm 12 x 2 mL vials Staclot® LA 2 x 1 mL vials of Buffer 2 x 0.25 mL vials of Phospholipids 4 x 0.5 mL vials of Normal Plasma 2 x 1 mL vials of PTT-LS 2 x 1.5 mL vials of Solvent Staclot® LA 20 Detection of Lupus Anticoagulants. Freeze-dried hexagonal phase phosphatidylethanolamine, normal human plasma with heparin inhibitor, PTT-LS reagent of cephalin and particulate activator (silica), 20 tests. 2 x 1 mL vials of Buffer 2 x 0.5 mL vials of Phospholipids 4 x 0.5 mL vials of Normal Plasma 2 x 2 mL vials of PTT-LS 2 x 2.5 mL vials of Solvent PTT-LA (LA Screen) 6 x 2 mL vials Pool Norm 12 x 1 mL vials Detection of Lupus Anticoagulants by the diluted Russell’s viper venom test by STA® analyzers. Russell’s viper venom, phospholipids (low concentration), calcium and heparin inhibitor, freeze-dried. 00333 Detection of Lupus Anticoagulants by the diluted Russell’s viper venom test by STA® analyzers. Russell’s viper venom, phospholipids (low concentration), calcium and heparin inhibitor, freeze-dried. 00334 Detection of Lupus Anticoagulants by the diluted Russell’s viper venom test by STA® analyzers. Russell’s viper venom, phospholipids (high concentration), calcium and heparin inhibitor, freeze-dried. 00600 Detection of Lupus Anticoagulants. Freeze-dried hexagonal phase phosphatidylethanolamine, normal human plasma with heparin inhibitor, PTT-LS reagent of cephalin and particulate activator (silica), 10 tests. 00594 00599 Lupus Anticoagulant sensitive APTT reagent. Cephalin reagent with particulate activator (silica), freeze-dried. 01139 For use as a normal control for the activated partial thromboplastin time (APTT) and dilute Russell’s viper venom time (dRVVT) assays. A lyophilized pool, consisting of at least 20 citrated normal human plasmas. 14 Product Catalog 2016 Fibrin Formation & Degradation Section 7 CAT. NO. PRODUCT/ DESCRIPTION CONTENTS 00515 STA -Liatest D-Di 6 x 5 mL vials of Buffer 6 x 6 mL vials of Latex Asserachrom® D-Di 3 x 2 Coated Strips 3 x 8 mL vials of Anti-D-Peroxidase 3 x 8 mL vials of TMB 3 x 50 mL bottles of Dilution Buffer 1 x 50 mL bottle of Washing Solution 3 x 0.5 mL vials of D-Di Calibrator 3 x 0.5 mL vials of D-Di Control 1 Plate Frame; 1 Plate Cover D-Di Test® 1 x 1.3 mL vial of Latex 1 x 20 mL bottle of Buffer 1 x 1 mL vial of Negative Control 1 x 1 mL vial of Positive Control 10 - Test Cards; Mixing Rods ® ® Immuno-turbidimetric assay of D-dimer by STA® analyzers. Microlatex particles coated with two different mouse monoclonal anti-human D-dimer antibodies. 00947 Enzyme immunoassay of D-dimer by ELISA method, 96 tests. 00454 Latex agglutination slide test for the qualitative and semi-quantitative determination of D-dimer in plasma, 60 tests. 00550 Test cards for D-Di Test kit 10 test cards 00540 1 x 1.3 mL vial of latex FDP Plasma Qualitative and semi-quantitative determination of fibrinogen degradation 1 x 1.3 mLvial of negative control 1 x 1.3 mL vial of positive control products (FDP) in plasma by latex agglutination. 1 x 1.3 mL vial of buffer 10 test cards mixing rods 00541 FDP Plasma (Latex) 12 x 1.3 mL vials of x 20 latex 00551 FDP Plasma (Buffer) 12 vials of buffer 00548 F.S./FDP Plasma Test Cards 10 test cards For use with catalog #00540 and #00887. 8 x 0.2 mL vials of F.S. Test Unit Reagent Stat detection of soluble fibrin monomer complexes by hemagglutination, 8 x 0.2 mL vials of Positive Control 8 x 0.2 mL vials of Negative Control 32 tests. 10 - Test Cards 00887 F.S. Test Unit 00857 F.S. Test 4 x 0.5 mL vials of F.S. Test Reagent Batch detection of soluble fibrin monomer complexes by hemagglutination, 4 x 0.5 mL vials of Positive Control 4 x 0.5 mL vials of Negative Control 40 tests. 15 Fibrinolysis Section 8 CAT. NO. PRODUCT/ DESCRIPTION CONTENTS 00658 STA®-Stachrom® Plasminogen 6 x 3 mL vials of Streptokinase 6 x 3 mL vials of Substrate STA®-Stachrom® Antiplasmin 4 x 2 mL vials of Plasmin 4 x 6 mL vials of Substrate 4 x 2 mL vials of Plasmin Solvent Asserachrom® tPA 3 x 2 Coated Strips 3 x 8 mL vials of Anti-tPA-Peroxidase 3 x 8 mL vials of TMB 3 x 50 mL bottle of Dilution Buffer 1 x 50 mL bottle of Washing Solution 3 x 0.5 mL vials of tPA Calibrator 3 x 0.5 mL vials of tPA Control 1 Plate Frame; 3 Plate Covers Chromogenic assay of plasminogen activity by STA® analyzers. 00659 Chromogenic assay of antiplasmin activity by STA® analyzers. 00948 Enzyme immunoassay of tissue plasminogen activator antigen by ELISA method, 96 tests. Primary Hemostasis Section 9 CAT. NO. PRODUCT/ DESCRIPTION CONTENTS 00518 STA -Liatest VWF:Ag 4 x 2 mL vials of Latex 4 x 4 mL vials of Latex Diluent 4 x 5 mL vials of Buffer Asserachrom® VWF:Ag 3 x 2 Coated Strips 3 x 8 mL vials of Anti-VWF-Peroxidase 3 x 8 mL vials of TMB 3 x 50 mL bottles of Dilution Buffer 1 x 50 mL bottle of Washing Solution 3 x 0.5 mL vials of VWF:Ag Calibrator 3 x 0.5 mL vials of VWF:Ag Control 1 Plate Frame; 1 Plate Cover Asserachrom® β-TG 3 x 2 Coated Strips 3 x 8 mL vials of Anti- β-TG-Peroxidase 3 x 8 mL vials of TMB 3 x 50 mL bottles of Dilution Buffer 1 x 50 mL bottle of Washing Solution 3 x 0.5 mL vials of β-TG Calibrator 3 x 0.5 mL vials of β-TG Control 1 Plate Frame; 1 Plate Cover Asserachrom® PF4 3 x 2 Coated Strips 3 x 8-mL vials of Anti-PF4-Peroxidase 3 x 8 mL vials of TMB 3 x 50 mL bottles of Dilution Buffer 1 x 50 mL bottle of Washing Solution 3 x 0.5 mL vials of PF4 Calibrator 3 x 0.5 mL vials of PF4 Control 1 Plate Frame; 1 Plate Cover ® ® lmmuno-turbidimetric assay of Von Willebrand Factor (VWF:Ag) Antigen by STA ® analyzers. Microlatex particles coated with rabbit anti-human VWF antibodies. 00942 Enzyme immunoassay of Von Willebrand Factor Antigen by ELISA method, 96 tests. 00950 Enzyme immunoassay for β-Thromboglobulin Antigen by ELISA method, 96 tests. 00951 Enzyme immunoassay for Platelet Factor 4 by ELISA method, 96 tests. 16 Product Catalog 2016 Control Plasmas Section 10 CAT. NO. PRODUCT/ DESCRIPTION CONTENTS 00381 STA®-Quality HNF/UFH 6 x 1 mL vials of STA® Quality HNF/UFH 2 6 x 1 mL vials of STA® Quality HNF/UFH 5 STA®-Coag Control N + ABN 12 x 1 mL vials of STA® Coag Control N 12 x 1 mL vials of STA® Coag Control ABN STA®-System Control N + P 12 x 1 mL vials of STA® System Control N 12 x 1 mL vials of STA® System Control P STA®-Liatest® Control N + P 12 x 1 mL vials of STA® Liatest® Control N 12 x 1 mL vials of STA® Liatest® Control P STA®-HBPM/LMWH Control 6 x 1 mL vials of STA®- Quality HBPM/LMWH Control 3 6 x 1 mL vials of STA®- Quality HBPM/LMWH Control 8 STA®-Heparin Control 6 x 1 mL vials of STA® Heparin Control 2 6 x 1 mL vials of STA® Heparin Control 5 STA®-Quality HBPM/LMWH 6 x 1mL vials of STA® Quality HBPM/LMWH Control 8 6 x 1mL vials of STA® Quality HBPM/LMWH Control14 STA®-Control LA 1 + 2 3 x 1 mL vials of STA® Control LA 1 3 x 1 mL vials of STA® Control LA 2 STA®-Coag Control N + ABN Plus 12 x 2 mL vials of STA® - Coag Control N Plus 12 x 2 mL vials of STA® - Coag Control ABN Plus Control plasma for assay of unfractionated heparin (UFH) using the STA ® Liquid Anti-Xa method on STA® analyzers. 00676 Multi-constituent normal and abnormal plasma controls for routine assays performed on the STA® analyzers. 00678 Multi-constituent normal and abnormal plasma controls for routine and specialty assays performed on the STA® analyzers. 00526US Normal and abnormal control plasmas for immuno-turbidimetric assays of VWF, D-dimer and Free Protein S on STA® analyzers. For use with STA® Liatest® VWF:Ag (#00518), STA® Liatest® D-DI (#00515) and STA® Liatest® Free Protein S (#00516). 00682 Control plasma for assays of low molecular weight heparin (LMWH) using the Anti-Xa method (Stachrom® Heparin). 00683 Control plasma for assays of unfractionated heparins (UFH) using the Anti-Xa method (Stachrom® Heparin). 00686 Control plasma for assays of low molecular weight heparins (LMWH) using the Anti-Xa method on STA® analyzers. 00201 Control plasmas for lupus anticoagulant (LA) detection. 00677 NEW Normal and abnormal control plasmas for PT INR, APTT, fibrinogen, thrombin time, and AT (activity) (24-hour stability) 17 Calibrators Section 11 CAT. NO. PRODUCT/ DESCRIPTION CONTENTS 00348 STA -Multi Hep Calibrator 4 X 1 mL vials of STA® Multi Hep Calibrator 0 4 X 1 mL vials of STA® Multi Hep Calibrator 4 4 X 1 mL vials of STA® Multi Hep Calibrator 7 4 X 1 mL vials of STA® Multi Hep Calibrator 10 4 X 1 mL vials of STA® Multi Hep Calibrator 18 STA®-Hepanorm® HBPM/LMWH 4 x 1 mLvials of STA® - Hepanorm® HBPM/LMWH 0 4 x 1 mL vials of STA® - Hepanorm® HBPM/LMWH 4 4 x 1 mL vials of STA® - Hepanorm® HBPM/LMWH 9 STA®-Hepanorm® H Calibration plasmas for assays of unfractionated heparin (UFH) using the Anti-Xa method (Stachrom® Heparin). 4 x 1 mL vials of STA® Hepanorm® H 0 4 x 1 mL vials of STA® Hepanorm® H 3 4 x 1 mL vials of STA® Hepanorm® H 6 STA®-VWF:Ag Calibrator 6 x 1 mL vials STA®-Unicalibrator 6 x 1 mL vials ® Calibration plasmas for both UFH and LMWH using the STA® Liquid Anti-Xa method on the STA® analyzers. 00681 Calibration plasmas for assays of low molecular weight heparin (LMWH) using the Anti-Xa method (Stachrom® Heparin). 00684 00520 Citrated human plasma for the calibration of VWF assays by the immuno-turbidimetric method on STA® analyzers. For use with STA® Liatest® VWF:Ag (#00518). 00675 Multi-constituent calibration plasma for functional assays of coagulation parameters on STA® analyzers. Section 12 18 Auxiliary Reagents CAT. NO. PRODUCT/ DESCRIPTION CONTENTS 00279 Polyethylene Glycol (PEG 25%) 6 x 2.5 mL 00360 STA®-Owren-Koller Buffer 24 x 15 mL 00367 STA®-CaCl2 0.025M 24 x 15 mL 00555 Asserachrom® Washing Solution 2 x 50 mL 00973 STA®-Cleaner Solution 6 x 2.5 L 00975US STA®-Desorb U 24 x 15 mL Product Catalog 2016 Quality & Compliance Solutions CAT. NO. PRODUCT/ DESCRIPTION Section 13 CONTENTS EQA (External Quality Assessment) Qualiris by Stago is a dedicated hemostasis proficiency testing program. Qualiris programs include routine (PT, APTT, Fibrinogen, and Thrombin Time) hemostasis tests and a wide variety of specialty tests including D-dimer, unfractionated heparin, low molecular weight heparin, factor assays and thrombophilia assays. Qualiris also offers a diagnostic challenge module for use as competency testing to satisfy continuing education requirements. Qualiris is an easy to use, web-based system which provides monthly, biannual, and annual reports with quantitative and qualitative statistics. Contact your sales representative for more information and to set up a custom comparison group. IQC (Internal Quality Control) Clarity Check Peer Program by Stago is a comprehensive quality control management program that offers peer comparison with the ability to create custom peer groups, pre-loaded reagent and QC lot information, 24/7 secure web based program with no need for additional hardware or software, and flexible report types to review monthly and cumulative data to monitor assay accuracy and precision. Core Programs 85145 Clarity Check Peer Program Clarity Check is a comprehensive quality control management program that offers: • peer comparison with the ability use create custom peer groups • pre-loaded reagent and QC lot information • 24/7 secure web based program with no need for additional hardware or software • flexible report types to review monthly and cumulative data 01044 Qualiris QC Premium Semester 1 12 x 1 mL Qualiris QC Premium Semester 2 12 x 1 mL Monthly external quality assessment of PT, APTT, Fibrinogen, Thrombin Time. 01045 Monthly external quality assessment of PT, APTT, Fibrinogen, Thrombin Time. Optional Add-On Programs 85093 Qualiris QC Premium Factors Monthly external quality assessment of Factors II, V, VII, VIII, IX, X, XI, XII, & VWF. 85094 Qualiris QC Premium Thrombophilia Monthly external quality assessment of Antithrombin, Protein C, Protein S, Plasminogen, Antiplasmin. 01047 Qualiris QC Heparin HBPM / LMWH 6 x 1 mL Qualiris QC Heparin HNF / UFH 6 x 1 mL Qualiris QC D-dimer 6 x 1 mL Qualiris QC Lupus Anticoagulant 3 x 1 mL Qualiris Diagnostic Challenge 6 x 1 mL External quality assessment of low molecular weight heparins. (6 times per year) 01048 External quality assessment of unfractionated heparin. (6 times per year) 01049 External quality assessment of D-dimer. (6 times per year) 01063 External quality assessment of lupus anticoagulant. (3 times per year) 01050 Competency assessment with unassayed sample and a Clinical Case History for CE credit.(3 cases per year) 19 Section 14 Stago Added Value on Request (SAVOR™) SAVOR™ (Stago Added Value on Request) offers tailored solutions for training, inventory management and other services to enhance productivity and efficiency. For additional details related to logistics and pricing contact your Stago Account Manager. Basic Operator Training Training at our Parsippany, New Jersey facility is included with each new instrument purchased. Price includes transportation, hotel, meals and training materials for in-house train-the-trainer implementation. Following the completion of this course, participants will be able to: • Recognize analyzer hardware • Prepare and load consumables/reagents • Complete practice runs included in the training materials • Understand the software • Perform user maintenance functions on the analyzer 20 CAT. NO. INSTRUMENTS 08416 STA Compact Max® & STA Compact® 08417 STA R Max® & STA-R Evolution® Product Catalog 2016 Stago Added Value on Request (SAVOR™) cont. Section 14 Reagent Application Technical Support 08427 On-Site Technical Assistance The Stago Technical Support Specialist will assist with adding a test parameter to a Stago instrument. Assistance could include test set-up, method validation, running test samples, and data collection and analysis. Stago Inventory Management 08431 Inventory Management and Shipping Stago often receives requests for customized inventory management solutions, including sequestering of products that typically would not be sequestered. A nominal fee is to charged for this customized solution. Requirements include: • Hard copy purchase order with specified quantity • Shipping schedule including beginning and end dates Lab Automation The STA R Max® and STA-R Evolution® can be integrated into a lab automation line. To accomplish the connection, a connection kit and/or additional accessory items may be required. A Stago automation consultant is available to answer questions and assure a smooth transition. CAT. NO. ACCESSORIES 80182 Kit TLA Type 2 Roche (STA-R Evolution®) 80950 Kit TLA Ortho Engen (STA-R Evolution®) 88517 Kit TLA Type 1 Universal (STA-R Evolution®) 88541 Ramp and Adjustment (STA R Max® and STA-R Evolution®) 89031 Kit TLA Type 1 Universal (STA R Max®) 89032 Kit TLA Type 1 Ortho Engen (STA R Max®) 89033 Kit TLA Type 2 Roche (STA R Max®) 21 Section 14 Stago Added Value on Request (SAVOR™) cont. Method Validation Standard Service: Accurate method validation is key to maintaining standardization and quality of results. In depth training and tools are provided during the new instrument training program. Standard method validation services include telephone support by your Stago Technical Support Specialist for review of protocols,to answer questions, and to provide final data review. SAVOR Method Validation Service: For customers who would prefer to have a Stago Technical Support Specialist on-site to coordinate and perform method validation, the Technical Support Specialist will run the tests, collect data, perform data analysis and provide an electronic data presentation. CAT. NO. DAYS OF ON-SITE SUPPORT SERVICE DESCRIPTION 08428 3 Routine Assays: PT, APTT, Fib, TT, D-dimer 08429 4 Routine + Specialty Assays CAT. NO. DESCRIPTION 85080 Method Validation Binder: For customers without access to a network enabled computer, Stago provides the convenience of a paper report. Lot Conversion Lot Conversion/Simple Method Validation (eg. a single test parameter) Lot Conversion: For customers who would prefer to have a Stago Technical Support Specialist on-site to perform a lot conversion, the Technical Support Specialist will run the tests, collect data, perform data analysis and provide an electronic data presentation. Method Validation: A Stago Technical Support Specialist will be on-site for one full day to perform method validation studies. Prior to arrival the Technical Support Specialist will work with the lead coagulation technologist/key operator to develop the plan for sample requirements and time management. The Technical Support Specialist will schedule a time to be present to run samples, generate data and complete the process. CAT. NO. DAYS OF ON-SITE SUPPORT SERVICE DESCRIPTION 08430 1 Routine Assay Lot Conversion Lot Conversion Analysis A Stago Technical Support Specialist will receive data generated by the lab via email, fax or other locally acceptable means of sharing data. The Technical Support Specialist will load the data into the appropriate template, review data for outliers, and provide a report back to the customer. 22 CAT. NO. SERVICE DESCRIPTION 08434 TSS Assistance: Lot Conversion Analysis Product Catalog 2016 Stago Added Value on Request (SAVOR™) cont. Section 14 Preventive Maintenance on Demand Preventive Maintenance on Demand is designed for customers who have a backup instrument that does not include a service contract. The Stago Field Service Group will perform a preventative maintenance program which includes decontamination of the instrument, general cleaning, instrument calibration, replacement of filters, and a biological test for precision. Price includes travel, parts and labor. CAT. NO. INSTRUMENT SERVICE DESCRIPTION 85075 STA Compact Max® & STA Compact® Preventative Maintenance 85076 STA R Max® & STA-R Evolution® Preventative Maintenance Instrument Decommission A Stago Field Service Engineer will decontaminate your retired coagulation instrument and remove the hard drive in compliance with local regulatory and HIPAA requirements. CAT. NO. SERVICE DESCRIPTION 85077 Decommission 85078 Decommission and return instrument to Stago for disposal 85079 Special visit to perform decommission procedure 23 Section 15 Thrombin Generation Research Products (Research Use only, not for use in diagnostic procedures) CAT. NO. PRODUCT/ DESCRIPTION CONTENTS Calibrated Automated Thrombogram® Thermo Electron Fluoroskan Ascent Analyzer Computer Thrombinoscope Software Operator’s reference manual Dongle Filters: 1 - 390 nm, 1- 460 nm Thrombin Calibrator 20 x 16 tests PPP Reagent 20 x 16 tests PPP Reagent LOW 20 x 16 tests PPP Reagent HIGH 20 x 16 tests PRP Reagent 20 x 16 tests FluCa Kit 10 x 16 tests MP Reagent 20 x 16 tests Instrument 86186 The Calibrated Automated Thrombogram® (CAT) measures the concentration of thrombin generated over time in clotting plasma using either platelet poor or platelet rich plasma. The CAT corrects for substrate consumption, the inner filter effect and color differences between plasmas by running a calibrator with every patient sample. The CAT provides a description of hyper- as well as hypo-activity of the clotting system. Reagents 86192 Corrects for substrate consumption, the inner filter effect and color differences between plasmas, which is necessary for use in parallel with each sample. 86193 Used with platelet poor plasma for general applications using the CAT System. 86194 Used with platelet poor plasma and has a high sensitivity to Factors VIII, IX and XI. This reagent increases sensitivity in hemophiliac plasma. 86195 Used with platelet poor plasma when thrombin generation is strongly inhibited. This reagent increases sensitivity in plasmas containing anticoagulants such as heparin. 86196 Used with platelet-rich plasma for thrombin generation measurements. PRP-Reagent can also be used in platelet-poor plasma to determine the presence of phospholipids and to examine the activity of phospholipid microparticles. 86197 Specific fluorogenic substrate and buffer suitable for thrombin generation. 86222 Used with platelet-free plasma and is specifically sensitive to circulating Tissue Factor present on the surface of procoagulant microparticles. Disposables & Accessories 86175 Immulon Round Bottom plate, 2HB 50/box 86176 Dispensing Tip 1 tip Thrombinoscope Package 1 Thrombinoscope software and 1 dongle 1 replacement tip for use with dispenser tip assembly of Calibrated Automated Thrombogram (CAT) instrument. 86191 Trombinoscope Software and dongle for running thrombin generation experiments via the Calibrated Thrombogram (CAT) platform. The Thrombinoscope Package can be purchased separately if the user already has a Fluoroskan Ascent® FL or Ascent® instrument along with a desktop computer with a RS232 serial port connection available. 24 Product Catalog 2016 Ecarin Chromogenic Assay (ECA) Products Section 16 (Research Use only, not for use in diagnostic procedures) CAT. NO. PRODUCT/ DESCRIPTION 01108 STA -ECA II 01109 STA®-Dabigatran Calibrator 2 x 3.5 mL Prothrombin Reagent Quantitative determination of dabigatran in plasma samples by the Ecarin 2 x 2 mL Substrate 2 x 2 mL Ecarin Reagent Chromogenic Assay (ECA) method. Calibration plasmas for dabigatran measurement using Ecarin Chromogenic Assay method. 01110 CONTENTS ® 2 x 1 mL vials of Calibrator 0 2 x 1 mL vials of Calibrator 1 2 x 1 mL vials of Calibrator 2 2 x 1 mL vials of Calibrator 3 2 x 1 mL vials of Calibrator 4 3 x 1 mL Vials of Control 1 Control plasmas for dabigatran measurement using Ecarin Chromogenic 3 x 1 mL Vials of Control 2 Assay method. STA®-Dabigatran Control 25 Flow Cytometry Research Products Section 17 (Research Use only, not for use in diagnostic procedures) CAT. NO. PRODUCT/ DESCRIPTION CONTENTS Flow Cytometry research kits from BioCytex 00111 Platelet Gp Receptors 5 tests The PLT Gp/Receptors kit allows precise quantitation of GpIIb, GpIb and GMP140 glycoproteins on platelet surfaces in the resting state and after TRAP (Thrombin Receptor Agonist Peptide) activation for detection of constitutive thrombopathies, including Glanzmann Thrombasthenia, Bernard Soulier syndrome, Fechtner syndrome, X-linked thrombocytopenia, and Gray platelet syndrome. 00112 Platelet Gpllb/llla Occupancy 10 tests Single color flow cytometric analysis of the GpIIb/IIIa glycoprotein receptor for testing of occupancy by various anti-GpIIb/IIIa drugs including abciximab (Reopro®), eptifibatide (Integrilin®), or tirofiban (Aggrastat®). 00418 Platelet Gp Screen 10 tests Single color flow cytometric analysis of the platelet glycoproteins GpIIIa, GpIb and GpIa. 00420 Megamix 50 tests For standardizing microparticle setup within a given analysis region (0.5-1 μm) and providing setting stability. 00449 Platelet VASP/P2Y12 10 tests For responsive testing of specific platelet ADP receptor (P2Y12) antagonists, including clopidogrel (Plavix®), prasugrel (Effient®), and ticagrelor (Brilinta®). 00452 Platelet PAlg Kit 10 tests For dual color flow cytometric analysis of Platelet Associated Immunoglobulins (PAIg). 00457 Platelet Calibrator 5 curves Calibration kit for the measurement of platelet glycoprotein expression level or any other human platelet surface molecules. 01000 Cellquant PNH 12 tests For analysis of deficiencies of CD55 and CD59 on the granulocyte surface for the purpose of analyzing samples from patients suspected of Paroxysmal Nocturnal Haemoglobinuria (PNH). 01001 Cellquant Calibrator 5 curves Calibration kit for the measurement of human leukocyte surface antigen expression level by multiple color analysis. 01003 Redquant PNH 12 tests For analysis of deficiencies of CD55 and CD59 on the red blood cell surface for the purpose of analyzing samples from patients suspected of Paroxysmal Nocturnal Haemoglobinuria (PNH). 01077 Megamix-Plus FSC 50 tests For standardizing microparticle setup within a given analysis region (0.3-1 µm) and providing setting stability. Designed for use with newer generation forward scatter (FSC)-optimized flow cytometer models such as the Gallios® or Navios® from Beckman Coulter. 01078 Megamix-Plus SSC 50 tests For standardizing microparticle setup within a given analysis region (0.3-1 µm) and providing setting stability. Designed for use with newer generation forward scatter (SSC)-optimized flow cytometer models from Becton Dickinson. 27 Section 17 Flow Cytometry Research Products (continued) (Research Use only, not for use in diagnostic procedures) CAT. NO. PRODUCT/ DESCRIPTION CONTENTS Monoclonal antibodies for flow cytometry from BioCytex 28 01005 Fibrinogen, clone 9F9, FITC 100 tests 01006 CD146, clone COM3D9, purified 100 tests 01007 CD146, clone COM2F6, purified 100 tests 01008 CD146, clone COM5G6, purified 100 tests 01009 CD146, clone COM7A4, Biotin 100 tests 01010 CD146, clone COM7A4, FITC 100 tests 01011 CD146, clone COM7A4, purified 100 tests 01012 CD146, clone S-Endo 1, Biotin 100 tests 01013 CD146, clone S-Endo 1, FITC 100 tests 01014 CD146, clone S-Endo 1, purified 100 tests 01015 CD146, clone S-Endo 1, PE 100 tests 01016 CD61, clone 4F8, FITC 100 tests 01017 CD61, clone 4F8, purified 100 µg 01018 Ctl. neg. lgG1 - FITC (2DNP2H11) 100 tests 01019 Ctl. neg. lgG1 purified (2DNP2H11) 100 µg 01020 Ctl. neg. lgG1 - PE (2DNP2H11) 100 tests 01021 CD62P, clone LYP20, FITC 100 tests 01022 CD62P, clone LYP20, purified 100 µg 01023 CD62P, clone LYP20, PE 100 tests 01024 CD41, clone PL2-49, FITC 100 tests 01025 CD41, clone PL2-49, purified 100 µg 01026 CD41, clone PL2-49, PE 100 tests 01027 CD42b, clone ALMA 19, FITC 100 tests 01028 CD42b, clone ALMA 19, purified 100 µg 01029 CD42b, clone ALMA 19, PE 100 tests 01030 CD36, clone 10.5, FITC 100 tests 01031 CD36, clone 10.5, purified 100 µg Product Catalog 2016 Flow Cytometry Research Products (continued) Section 17 (Research Use only, not for use in diagnostic procedures) CAT. NO. PRODUCT/ DESCRIPTION CONTENTS Monoclonal antibodies for flow cytometry from BioCytex 01032 CD36, clone 10.5, PE 100 tests 01033 CD32, clone 2B2, purified 100 µg 01034 Ctl. neg. lgG2b-FITC (2DNP14G5) 100 tests 01035 Ctl. neg. lgG2b purified (2DNP14G5) 100 µg 01036 Ctl. neg. lgG2b PE (2DNP14G5) 100 tests 01037 Ctl. neg. lgG2a-FITC (2DNP16C12) 100 tests 01038 Ctl. neg. lgG2a purified (2DNP16C12) 100 µg 01039 Ctl. neg. lgG2a - PE (2DNP16C12) 100 tests 01040 CD61, clone LYP18, FITC 100 tests 01041 CD61, clone LYP18, purified 100 µg 01042 CD61, clone LYP18, PE 100 tests 100 µg 01083 Anti-human GPVI, purified 100 µg 01084 Anti-human GPVI, PE 100 tests 29 Section 18 Research Kits (Research Use only, not for use in diagnostic procedures) CAT. NO. PRODUCT/ DESCRIPTION 00261 Asserachrom® Total TFPI 00262 Asserachrom® Free TFPI 00264 Asserachrom® sEPCR 3 x 2 Coated Strips 3 x 8 mL vials of Anti-sEPCR-Peroxidase 3 x 8 mL vials of TMB 3 x 50 mL bottles of Dilution Buffer 1 x 50 mL bottle of Washing Solution 3 x 0.5 mL vials of sEPCR Calibrator 3 x 0.5 mL vials of sEPCR Control 1 Plate Frame; 1 Plate Cover Asserachrom® Anti-Prothrombin IgG,M 3 x 2 Coated Strips 3 x 4 mL vials of Anti-IgG-Peroxidase 3 x 4 mL vials of Anti-IgM-Peroxidase 3 x 8 mL vials of TMB 3 x 50 mL bottles of Dilution Buffer 1 x 50 mL bottle of Washing Solution 3 x 2 mL vials of Anti-Prothrombin IgG,M Calibrator 3 x 2 mL vials of Control 1 3 x 2 mL vials of Control 2 1 Plate Frame; 1 Plate Cover Asserachrom® Soluble GPV 3 x 2 Coated Strips 3 x 8 mL vials of Anti-sGPV-Peroxidase 3 x 8 mL vials of TMB 3 x 50mL bottles of Dilution Buffer 1 x 50 mL bottle of Washing Solution 3 x 0.5 mL vials of sGPV Calibrator 3 x 0.5 mL vials of sGPV Control 1 Plate Frame; 1 Plate Cover Asserachrom® VIII:Ag 3 x 2 Coated Strips 3 x 8 mL vials of Anti- F.VIII:Ag-Peroxidase 3 x 8 mL vials of TMB 3 x 50mL bottles of Dilution Buffer 1 x 50 mL bottle of Washing Solution 3 x 0.5 mL vials of F. VIII:Ag Calibrator 3 x 0.5 mL vials of F. VIII:Ag Control 1 Plate Frame; 3 Adhesive Films Staclot® VIIa-rTF 2 x 2 mL vials of Buffer 2 x 1 mL vials of F. VII Deficient Plasma 2 x 1 mL vials of rsTF-Phospholipids 2 x 0.5 mL vials of F. VIIa Calibrator 2 x 0.5 mL vials of F. VIIa Control 1 2 x 0.5 mL vials of F. VIIa Control 2 3 x 2 Coated Strips Quantitative determination of total Tissue Factor Pathway Inhibitor (TFPI) 3 x 2 mL vials of Anti-Total TFPI-Peroxidase 6 tablets of Ortho-Phenylenediamine by ELISA method, 96 tests. 2 x 50 mL bottles of Dilution Buffer 1 x 50 mL bottle of Washing Solution 3 x 0.5 mL vials of Total TFPI Calibrator 3 x 0.5 mL vials of Total TFPI Control 1 Plate Frame; 1 Plate Cover 6 tablets of Urea Peroxide 3 x 2 Coated Strips Quantitative determination of free Tissue Factor Pathway Inhibitor (TFPI) 3 x 2 mL vials of Anti-Free TFPI-Peroxidase 6 tablets of Ortho-Phenylenediamine by ELISA method, 96 tests. 6 tablets of Urea Peroxide 2 x 50 mL bottles Dilution Buffer 1 x 50 mL bottle of Washing Solution 3 x 0.5 mL vials of Free TFPI Calibrator 3 x 0.5 mL vials of Free TFPI Control 1 Plate Frame; 1 Plate Cover Quantitative determination of soluble Endothelial Protein C Receptor by ELISA method, 96 tests. 00265 Semi-quantitative determination of anti-prothrombin antibodies of IgG and/or IgM class by ELISA method, 96 tests. 00276 Quantitative determination of soluble Glycoprotein V by ELISA method, 96 tests. 00280 Quantitative determination of Factor VIII Antigen by ELISA method, 96 tests. 00281 Clotting assay of activated Factor VII, 20 tests. 30 CONTENTS Product Catalog 2016 Research Kits (continued) Section 18 (Research Use only, not for use in diagnostic procedures) CAT. NO. PRODUCT/ DESCRIPTION CONTENTS 00346 STA -Stachrom TAFI 2 x 2 mL vials of TAFI Activator 2 x 2 mL vials of Substrate 4 x 4 mL vials of Carboxypeptidase A 2 x 1 mL vials of TAFI Calibator 2 x 1 mL vials of TAFI Control STA®-Procoag-PPL 3 x 1 mL vials of P-PPL Depleted plasma 3 x 4 mL vials of F.Xa, ~0.040 IU/vial 3 x 1 mL vials of P-PPL Control N 3 x 1 mL vials of P-PPL Control P Asserachrom® Vlla-AT 3 x 2 Coated Strips 3 x 8 mL vials of Anti-AT-Peroxidase 3 x 8 mL vials of TMB 3 x 50 mL Bottles of Sample Buffer 3 x 15 mL vials of Dilution Buffer 3 x 0.5 mL vials of Vlla-AT Calibrator 3 x 0.5 mL vials of Vlla-AT Control 1 Plate Frame; 1 Adhesive Film 1 x 50 mL bottle of Washing Solution STA®-Liatest® FM 6 x 2 mL vials of Buffer 6 x 4 mL vials of Latex 90 tests STA®-FM Calibrator A set of calibrator plasmas intended for calibration of the immunoturbidimetric method. To be used with 00543US. 2 x 1 mL vials of calibrator 1 2 x 1 mL vials of calibrator 2 2 x 1 mL vials of calibrator 3 2 x 1 mL vials of calibrator 4 2 x 1 mL vials of calibrator 5 STA®-FM Control 6 x 1 mL vials of control 1 6 x 1 mL vials of control 2 Liatest® C4b-BP 6 x 1 mL vials of Latex 6 x 4 mL vials of Buffer Asserachrom® TAFIa/TAFIai 3 x 2 Coated Strips 3 x 8 mL vials of Anti-TAFIa/TAFIai-Peroxidase 3 x 8 mL vials of TMB 3 x 50 mL Bottles of Dilution Buffer 1 x 50 mL Bottle of Washing Solution 3 x 0.5 mL vials of TAFIa/TAFIai Calibrator 3 x 0.5 mL vials of TAFIa/TAFIai Control 1 Plate Frame; 1 Plate Cover STA®-Rivaroxaban Calibrator Calibration plasmas for rivaroxaban measurement using chromogenic anti-Xa Method. 3 x 1 mL vials of Calibrator 1 3 x 1 mL vials of Calibrator 2 3 x 1 mL vials of Calibrator 3 3 x 1 mL vials of Calibrator 4 STA®-Rivaroxaban Control 3 x 1 mL vials of Control 1 3 x 1 mL vials of Control 2 Stachrom® Heparin Cofactor II 6 x 2 mL vials of Thrombin 6 x 2 mL vials of Substrate 1 x 15 mL bottle of Buffer ® ® Quantitative determination of thrombin activable fibrinolysis inhibitor activity, Chromogenic Assay, 60 tests. 00429 Clot-based assay for the detection of procoagulant phospholipids by STA® analyzer, 60 tests. 00491 Quantitative determination of the FVlla-AT complex by ELISA method, 96 tests. 00543US Immuno-turbidimetric assay of Fibrin Monomer by STA® analyzers. Microlatex particles coated with two different mouse monoclonal anti-human fibrin monomer antibodies, 90 tests. 00544US 00545US Two plasmas intended for the quality control of the immunoturbidimetric method. To be used with 00543US. 00581 Quantitative determination of C4b-BP by Immuno-turbidimetric measurement, 60 tests. 00616 Quantitative determination of TAFIa/TAFIai by ELISA method, 96 tests. 00704US 00706US Control plasmas for rivaroxaban measurement using chromogenic anti-Xa Method. 00851 Chromogenic assay of heparin cofactor II activity, 60 tests. 31 Section 18 Research Kits (continued) (Research Use only, not for use in diagnostic procedures) CAT. NO. PRODUCT/ DESCRIPTION CONTENTS 00853 Stachrom PAI 2 x 2 mL vials of Urokinase 2 x 2 mL vials of Plasminogen 2 x 2 mL vials of Substrate 2 x 0.5 mL vials of PAI Calibrator 1 2 x 0.5 mL vials of PAI Calibrator 2 2 x 0.5 mL vials of PAI Calibrator 3 Asserachrom® PAI-1 3 x 2 Coated Strips 3 x 8 mL vials of Anti-PAI-1-Peroxidase 3 x 8 mL vials of TMB 3 x 50 mL bottles of Dilution Buffer 1 x 50 mL bottle of Washing Solution 3 x 2 mL vials of PAI-1 Calibrator 3 x 2 mL vials of PAI-1 Control 1 Plate Frame; 1 Plate Cover Asserachrom® VII:Ag 3 x 2 Coated Strips 3 x 8 mL vials of Anti-VII:Ag Peroxidase 3 x 8 mL vials of TMB 3 x 50 mL vials Dilution Buffer 1 x 50 mL vial Washing Solution 3 x 0.5 mL vials of F. VII:Ag Calibrator 3 x 0.5 mL vials of F. VII:Ag Control 1 Plate Frame 1 Plate Cover Asserachrom® X:Ag 3 x 2 Coated Strips 3 x 8 mL vials of Anti-X:Ag Peroxidase 3 x 8 mL vials of TMB 3 x 50 mL vials Dilution Buffer 1 x 50 mL vial Washing Solution 3 x 0.5 mL vials of F. X:Ag Calibrator 3 x 0.5 mL vials of F. X:Ag Control 1 Plate Frame 1 Plate Cover Cy-Quant CD146 3 x 2 Coated Strips 3 vials of Calibrator 1 vial of Stop Solution 1 vial of TMB 1 vial of Washing solution 1 vial of Dilution buffer 1 vial of Anti CD146-peroxidase 1 vial of Control plasma 1 Plate Frame STA®-Apixaban Control 3 x 1 mL vials of Control 1 3 x 1 mL vials of Control 2 STA®-Apixaban Calibrator 3 x 1 mL vials of calibrator 1 3 x 1 mL vials of calibrator 2 3 x 1 mL vials of calibrator 3 3 x 1 mL vials of calibrator 4 Asserachrom® VWF: FVIIIB 3 x 2 Coated Strips 3 x 8 mL vials of recombinant FVIII 3 x 8 mL vials of Anti-FVIII-Peroxidase 3 x 8 mL vials of TMB 3 x 15 mL vials of Dilution Buffer 3 x 20 mL vials of Reconstitution Buffer 1 x 50 mL bottle of Washing Solution 3 x 2 mL vials of vWF:FVIIIB Calibrator 3 x 2 mL vials of vWF:FVIIIB Control 1 Plate Frame; 1 Plate Cover ® Chromogenic assay of plasminogen activator inhibitor activity, 20 tests. 00949US Quantitative determination of plasminogen activator inhibitor-1 Antigen (PAI-1) by ELISA method, 96 tests. 00955 Quantitative determination of Factor VII:Ag by ELISA method, 96 tests. 00956 Quantitative determination of Factor X:Ag by ELISA method, 96 tests. 01004 For the determination of soluble CD146 (sCD146, S-ENDO 1, MUC 18, melanoma cell adhesion molecule) in plasma and serum, by ELISA method, 96 tests. 01111 Control plasmas for apixaban measurement using chromogenic anti-Xa Method. 01112 Calibration plasmas for apixaban mesurement chromogenic anti-Xa Method. 01138 Kit for the quantitative determination of the capacity of von Willebrand factor to bind to factor VIII (VWF:FVIIIB) by enzyme-linked immunosorbent assay (ELISA), 96 tests. 32 Product Catalog 2016 Research Components Section 19 (Research Use only, not for use in diagnostic procedures) CAT. NO. PRODUCT/ DESCRIPTION CONTENTS Purified Proteins a 00461 Purified VWF 100 µg 00462 Purified Factor X 20 Plasma Equivalent Units (PEU), approx 200 μg 00463 Purified Heparin Cofactor II 1 Plasma Equivalent Units (PEU), approx 100 μg 00519 Purified Fibrinogen 8 mg 00557 Purified Prothrombin 5 Plasma Equivalent Units (PEU), approx 500 μg 00828 Purified APC 10 μg 00888 Purified AT III 150 μg 00896 Purified Thrombin 1000 NIH Units 00912 Purified Factor Xa 10 μg Chromogenic Substratesb 00811 CBS 31.39 (Substrate for Factor Xa) 1 vial, 7.5 μMoles 00873 CBS 34.47 (Substrate for Thrombin) 1 vial, 7.5 μMoles Venoms and Inhibitorsb 00823 Ecarin 1 vial, 50 Ecarin Units (EU) 00830 r-Hirudin 1 vial, 2,000 r-Hirudin Antithrombin Units (ATU) b All chromogenic substrates, venoms and inhibitors are freeze-dried. a Purified proteins are freeze-dried and are from human sources. 33 Abbreviations ABBREVIATION NAME 34 ABBREVIATION NAME α2-AP Alpha-2-Antiplasmin GPO Group Purchasing Organization ACA Anticardiolipin Antibodies GPV Glycoprotein V APA Antiphospholipid Antibody(ies) HBPM Héparines de bas poids moléculaire (French designation for LMWH) APC Activated Protein C HNF Heparines non fraccionee APTT Activated Partial Thromboplastin Time LA Lupus Anticoagulants AT Antithrombin LMWH Low Molecular Weight Heparin AT:Act Antithrombin Activity N+ABN Normal and Abnormal AT:Ag Antithrombin Antigen N+P Normal and Pathologic CaCl2 Calcium Chloride OPD Ortho-phenylenediamine DIC Disseminated Intravascular Coagulation PAI 1 Plasminogen Activator Inhibitor 1 DSI Diagnostica Stago Inc PC Protein C ELISA Enzyme-Linked Immunosorbent Assay PF4 Platelet Factor 4 Fib Fibrinogen PIVKA Protein Induced by Vitamin K Antagonists FDP Fibrinogen Degradation Products PNP Pooled Normal Plasma FII Factor II or Prothrombin PS Protein S FOB Free On Board PT Prothrombin Time FSE Field Service Engineer PTT-LA LA Sensitive APTT FV Factor V TAFI Thrombin Activable Fibrinolysis Inhibitor FVII Factor VII TFPI Tissue Factor Pathway Inhibitor FVIII Factor VIII TMB Tetra Methyl Benzidine FIX Factor IX TSS Technical Support Specialist FX Factor X TT Thrombin Time FXI Factor XI UFH Unfractionated Heparin FXII Factor XII VWD Von Willebrand Disease FM Fibrin Monomer VWF Von Willebrand Factor Product Catalog 2016 HEM tPA OS TA S P A I-1 FDP D-Dimer SI Plasminogen Plasmin Fibrin TM Fibrinogen IIa PC A T IIa APC PS II PS V AP C A Va T Activated Platelet Xa vWF X A T IXa VIIIa APC PS XI IX A T XIa VIII Inhibition pathways Activation pathways Coagulation Fibrinolysis Xa TFPI VIIa AT TF AT THE HEART OF HEMOSTASIS AT PAI-1 APC PS Xa TFPI Terms and Conditions of Sale FOR REAGENTS, DISPOSABLES & ACCESSORIES Definitions: Products: Reagents, Disposables and Accessories as defined in DSI’s Product catalog in force. DSI: Diagnostica Stago, Inc., a Delaware corporation with its principal place of business at Five Century Drive, Parsippany, NJ 07054, the seller of the Products. Customer: The person or entity purchasing the Products. Ordering Information: Please reference your Customer number when placing all orders. Orders are accepted by telephone or fax: Attn: Sales Administration Department Phone: (800) 222-COAG (2624) Menu option 3 Fax: (973) 426-9460 Monday through Friday: 8:30 am to 5:00 pm (Eastern Time) By mail, please refer all orders to: Diagnostica Stago, Inc. Attn: Sales Administration Department 330 Waterloo Valley Road Mount Olive NJ 07828 Application: These Terms and Conditions of Sale supersede any terms specified in the purchase order placed by Customer or related correspondence. Any additions, modifications or deletions made to these Terms and Conditions of Sale shall be null and void unless approved in writing by DSI. The failure or delay of DSI to enforce any of these Terms and Conditions of Sale shall not be deemed to be a waiver by DSI of any such terms. If, at the time of purchase, Customer is a qualified member of a Group Purchasing Organization (GPO) having a contract with DSI, conflicting provisions in these Terms and Conditions of Sale will be interpreted as per the contract between said GPO and DSI in effect at the time of purchase. Payment: The prices for the Products are those indicated in DSI’s price lists in effect at the time the order is placed by Customer. A $50.00 minimum purchase is required. Terms of payment are net 30 days from the date of DSI’s invoice. Customer shall report any incorrect billing to DSI Sales Administration within 15 days after the delivery of invoice. Customer agrees to reimburse DSI on demand for any taxes, fines or penalties paid by DSI on behalf of Customer. DSI will not bill third party providers for such payments. DSI reserves the right, in addition to all other remedies available, at its sole discretion and without prior notice (i) to suspend deliveries of Products and to reject any new orders made unless and until payment in full is made by Customer of all outstanding amounts due to DSI and (ii) to charge interest on past due amounts at the rate of one and one half percent (11/2%) per month until paid or the lesser maximum amount permitted by law. Delivery: Products shall be delivered FOB Origin, freight prepaid and added to the invoice. Delivery of the Products shall be deemed to have occurred at the earlier of: (i) the date the Products are handed over to the first carrier, or (ii) in case of an unsuccessful attempt at shipment, two business days following the sending of notice to Customer stating that Products are at Customer’s disposal at DSI’s shipping point. 36 Product Catalog 2016 Sequestering: Reagents to be sequestered (by storing a pre-established quantity of a single lot of Reagent) are determined by DSI based on Customer’s sequestering request. Sequestering will require a hard copy Purchase Order indicating line item quantity and a specified delivery schedule including beginning and end dates. First delivery of sequestered Reagents cannot be less than 30 days from the date of the sequestering request. Returns: Customer may not return Reagents ordered in error. Returns will not be accepted or a credit issued without prior approval and a Return Authorization Number assigned by a Sales Administration Representative. Please call (800) 222-COAG Menu option 3. Two categories of returns will be accepted: 1) Products shipped in error by DSI, and 2) Analyzer parts, disposables, or accessories, ordered in error by Customer may be returned provided a Return Authorization number is assigned by a Sales Administration Representative, the item is returned in the original unopened packaging, and received undamaged. However, in category 2), Customer will be charged a 35% restocking fee. In order to receive replacement Product or credit, the following criteria must be met: The problem must be reported within 30 working days from the date stated on the Product invoice; Returned Product must be in the same condition as it was received; No returns will be accepted after 30 days from the date on the Product invoice. Please send all returns indicating the Return Authorization Number on the outside of the package to: Diagnostica Stago, Inc. Return’s Department Distribution Warehouse 330 Waterloo Valley Road Mount Olive, NJ 07828 Limited Warranty: Each of the Products shall be free from defects in material and workmanship and shall conform to DSI’s specifications as specified in the package when delivered by DSI. Subject to DSI’s acceptance of the non-conformity of the Products delivered, the warranty for defective Products is strictly limited to the replacement free of charge of the corresponding Products. EXCEPT TO THE EXTENT OF THE LIMITED WARRANTY SPECIFICALLY SET FORTH IN THIS ARTICLE, AND NOTWITHSTANDING ANY PROVISION TO THE CONTRARY CONTAINED HEREIN OR IN ANY OTHER DOCUMENT, NO WARRANTY OR GUARANTEE, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR USE, IS MADE. In no event shall DSI, its employees or its suppliers be liable for lost profits or any special common, indirect, incidental, consequential or exemplary damages, irrespective of whether attributable to contract, warranty, negligence, strict liability or otherwise. Governing Law – Venue: These Terms and Conditions of Sale shall be governed by and interpreted in accordance with, the laws of the State of New York applicable to contracts made and wholly performed in New York. All disputes arising out of or in connection with the order made under these Terms and Conditions of Sale must be settled by one Arbitrator sitting in New York City, in accordance with the Commercial Arbitration Rules of the American Arbitration Association, and judgment upon the award rendered by the Arbitrator may be entered in any Court having jurisdiction over the parties. Main Index ITEM PAGE(S) Anti-human GPVI, PE ......................................................29 Anti-human GPVI purified................................................29 Asserachrom® Anti-Prothrombin IgG, M.........................30 Asserachrom® D-Di.........................................................15 Asserachrom® Free Protein S..........................................13 Asserachrom® Free TFPI.................................................30 Asserachrom® PAl- 1.......................................................32 Asserachrom® Protein C..................................................13 Asserachrom® sEPCR......................................................30 Asserachrom® Soluble GPV.............................................30 Asserachrom® Total Protein S.........................................13 Asserachrom® Total TFPI.................................................30 Asserachrom® tPA...........................................................16 Asserachrom® VII:Ag.......................................................32 Asserachrom® VIII:Ag......................................................30 Asserachrom® VWF:Ag...................................................16 Asserachrom® VWF:FVIIIB..............................................32 Asserachrom® X:Ag.........................................................32 Asserachrom® ß-TG ........................................................16 Asserachrom® HPIA (ELISA)...........................................12 Asserachrom® IX:Ag........................................................ 11 Asserachrom® PF4..........................................................16 Calibrated Automated Thrombogram®............................24 CBS 31.39.......................................................................33 CBS 34.47.......................................................................33 CD146, clone COM2F6, purified....................................28 CD146, clone COM3D9, purified...................................28 CD146, clone COM5G6, purified...................................28 CD146, clone COM7A4, Biotin.......................................28 CD146, clone COM7A4, FITC.........................................28 CD146, clone COM7A4, purified....................................28 CD146, clone S-Endo 1, Biotin.......................................28 CD146, clone S-Endo 1, FITC.........................................28 CD146, clone S-Endo 1, PE............................................28 CD146, clone S-Endo 1, purified....................................28 CD32, clone 2B2, purified..............................................29 CD36, clone 10.5, FITC...................................................28 CD36, clone 10.5, PE......................................................29 CD36, clone 10.5, purified..............................................28 CD41, clone PL2-49, FITC..............................................28 CD41, clone PL2-49, PE.................................................28 CD41, clone PL2-49, purified.........................................28 CD42b, clone ALMA 19, FITC.........................................28 CD42b, clone ALMA 19, PE............................................28 CD42b, clone ALMA 19, purified....................................28 CD61, clone 4F8, FITC....................................................28 CD61, clone LYP18, FITC................................................29 CD61, clone LYP18, PE...................................................29 CD61, clone LYP18, purified...........................................29 CD61, clone 4F8, purified...............................................28 ITEM PAGE(S) CD62P, clone LYP20, FITC..............................................28 CD62P, clone LYP20, PE.................................................28 CD62P, clone LYP20, purified.........................................28 Cellquant calibrator..........................................................27 Cellquant PNH.................................................................27 Ctl. Neg. lgG1 - FITC (2DNP2H11)..................................28 Ctl. Neg. lgG1 - PE (2DNP2H11).....................................28 Ctl. Neg. lgG1 - purified (2DNP2H11).............................28 Ctl. Neg. lgG2a PE (2DNP16C12)...................................29 Ctl. Neg. lgG2a purified (2DNP16C12)...........................29 Ctl. Neg. lgG2a - FITC (2DNP16C12)..............................29 Ctl. Neg. lgG2b - FITC (2DNP14G5)...............................29 Ctl. Neg. lgG2b PE (2DNP14G5)....................................29 Ctl. Neg. lgG2b purified (2DNP14G5)............................29 D-Di Test®........................................................................15 Dispensing Tip.................................................................24 Ecarin Chromogenic Assay (ECA)....................................25 External Quality Assessment Program.............................19 F.S. Test............................................................................15 F.S. Test Unit....................................................................15 FDP Plasma......................................................................15 FDP Plasma Buffer...........................................................15 FDP Plasma Latex............................................................15 Fibrinogen, clone 9F9, FITC.............................................28 FluCa Kit...........................................................................24 FS/FDP Plasma Test Cards..............................................15 Halogen Lamp...................................................................7 Internal Quality Control Peer Program ............................19 Immulon Round Bottom plate, 2HB................................24 Liatest® AT III...................................................................12 Liatest® C4b-BP...............................................................31 Liatest® Protein S.............................................................12 Megamix..........................................................................27 Miscellaneous Parts..........................................................8 MP Reagent.....................................................................24 PAlg kit.............................................................................27 Platelet Calibrator.............................................................27 Platelet GP Receptors......................................................27 Platelet Gp Screen...........................................................27 Platelet gpllb/llla Occupancy...........................................27 Platelet VASP/P2Y12.......................................................27 Polyethylene Glycol.........................................................18 Pool Norm.......................................................................14 PPP Reagent....................................................................24 PPP Reagent HIGH..........................................................24 PPP Reagent LOW...........................................................24 PRP Reagent....................................................................24 PTT-LA.............................................................................14 Purified APC....................................................................33 Purified AT III...................................................................33 37 Main Index ITEM PAGE(S) Purified Factor X..............................................................33 Purified Factor Xa.............................................................33 Purified Fibrinogen..........................................................33 Purified Heparin Cofactor II.............................................33 Purified Thrombin............................................................33 Purified VWF....................................................................33 r-Hirudin..........................................................................33 Redquant PNH.................................................................27 STA®-Apixaban Calibrator................................................32 STA®-Apixaban Control....................................................32 STA®-Rivaroxaban Calibrator...........................................31 STA®-Rivaroxaban Control...............................................31 STA®-C.K. Prest 5 ...........................................................10 STA®-CaCl2.......................................................................18 STA®-Cleaner Solution.....................................................18 STA®-Coag Control N + ABN........................................... 17 STA®-Coag Control N + ABN Plus................................... 17 STA Compact Max® Coagulation System..........................4 STA Compact Max® Coag System with Cap Piercing........4 STA®-Control LA 1 + 2..................................................... 17 STA®-Deficient II.............................................................. 11 STA®-Deficient IX............................................................. 11 STA®-Deficient V ............................................................. 11 STA®-Deficient VII ........................................................... 11 STA®-Deficient VIII........................................................... 11 STA®-Deficient X.............................................................. 11 STA®-Deficient XI............................................................. 11 STA®-Deficient XII............................................................ 11 STA®-Desorb U................................................................18 STA®-Fibrinogen 5...........................................................10 Stago Added Value on Request (SAVOR).........................20 STA®-HBPM/LMWH Control........................................... 17 STA®-Hepanorm H...........................................................18 STA®-Hepanorm® HBPM/LMWH....................................18 STA®-Heparin Control...................................................... 17 STA®-Liatest® Control N + P ........................................... 17 STA®-Liatest® D-Di..........................................................15 STA®-Liatest® Free Protein S............................................12 STA®-Liatest® VWF:Ag.....................................................16 STA®-Multi Hep Calibrator...............................................18 STA®-Neoplastine ® CI 5..................................................10 STA®-Neoplastine ® CI Plus 10........................................10 STA®-Neoplastine ® CI Plus 5..........................................10 STA®-Owren-Koller Buffer...............................................18 STA®-Procoag - PPL.........................................................31 STA®-PTT Automate 5.....................................................10 STA®-Quality HBPM/LMWH........................................... 17 STA®-Reptilase.................................................................10 38 Product Catalog 2016 ITEM PAGE(S) STA -Liquid Anti-Xa 4......................................................12 STA®-Liquid Anti-Xa 8......................................................12 STA® Satellite® Hemostasis System..................................5 STA®-Stachrom® Antiplasmin..........................................16 STA®-Stachrom® AT III.....................................................13 STA®-Stachrom® Plasminogen.........................................16 STA®-Stachrom® Protein C..............................................13 STA®-Stachrom® TAFI......................................................31 STA®-Staclot® DRVV Confirm..........................................14 STA®-Staclot® DRVV Screen 2.........................................14 STA®-Staclot® DRVV Screen 5.........................................14 STA®-Staclot® Protein C...................................................13 STA®-Staclot® Protein S...................................................13 STA®-System Control N + P............................................. 17 STA®-Thrombin 10...........................................................10 STA®-Thrombin 2.............................................................10 STA®-Unicalibrator...........................................................18 STA®-VWF:Ag Calibrator .................................................18 STA-R® Family, STA Compact Max® and ........................ 7-8 STA Satellite® Disposables and Accessories STA R Max® Hemostasis System.......................................3 Stachrom® Heparin..........................................................12 Stachrom® Heparin Cofactor II........................................33 Stachrom® PAI.................................................................32 Staclot® LA......................................................................14 Staclot® LA 20 ................................................................14 Staclot® VIIa-rTF..............................................................30 STart® Disposables and Accessories................................8 STart® Hemostasis Analyzer..............................................6 Test cards for D-Di Test kit...............................................15 Thrombin Calibrator.........................................................24 ® Notes ................................................................................................................................................ ................................................................................................................................................ ................................................................................................................................................ ................................................................................................................................................ ................................................................................................................................................ 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Product Catalog 2016 agenceL2R.com - ©2014 Diagnostica Stago - All rights reserved - Non-contractual photos - PROM-14-033 v A, Effective Date: 01/2016