Family of - Isla Lab Products
Transcription
Family of - Isla Lab Products
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. All STA® systems share the following characteristics: MODELS: AUTOMATED STA-R Evolution® Expert Series: Automation capable, high throughput STA Compact®: Medium 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® REAGENT MENU PT APTT Fibrinogen D-dimer (Quantitative) Thrombin Time Reptilase Time Extrinsic Factors Intrinsic Factors Unfractionated Heparin (UFH) Low Molecular Weight Heparin (LMWH) Antithrombin (AT) Activity Protein C Activity (clot-based and chromogenic) Protein S Activity Free Protein S Antigen DRVV Screen and Confirm VWF Antigen Plasminogen Activity Antiplasmin Activity Fibrin Monomer* Ribaroxaban* Lupus Anticoagulants DRVVT PTT-LA Staclot LA Antithrombin (AT) Antigen Total Protein S Antigen *(research use only; not for use in diagnostic procedures) Instruments................................................................................................................................ 3 Disposables & Accessories......................................................................................................... 7 Screening Tests......................................................................................................................... 10 Factor Assays............................................................................................................................ 11 Anticoagulants......................................................................................................................... 12 Thrombophilia ........................................................................................................................ 12 Fibrin Formation and Degradation......................................................................................... 15 Fibrinolysis............................................................................................................................... 16 Primary Hemostasis................................................................................................................. 16 Control Plasmas....................................................................................................................... 17 Calibrators................................................................................................................................ 17 Auxiliary Reagents................................................................................................................... 18 External Quality Assessment Program (Qualiris).................................................................... 19 Stago Added Value on Request (SAVORTM)............................................................................... 20 Thrombin Generation Research Products............................................................................... 26 Ecarin Chromogenic Assay (ECA) Products............................................................................. 27 Flow Cytometry Research Products........................................................................................ 29 Research Kits........................................................................................................................... 31 Research Components............................................................................................................ 34 Abbreviations.......................................................................................................................... 36 Terms & Conditions................................................................................................................ 38 Main Index ........................................................................................................................ 39-40 Product Catalog 1 Section. s 1 Instruments CAT. NO. PRODUCT / DESCRIPTION 58978 STA-R Evolution® Expert Series Hemostasis System Automation-Capable, High-Throughput Hemostasis Analyzer 58979 STA-R Evolution® Expert Series Hemostasis System with Cap Piercing Automation-Capable, High-Throughput Hemostasis Analyzer The newest generation STA-R Evolution® Expert Series is a fully automated, hemostasis analyzer with laboratory automation connection capability. Clotting, chromogenic and immunological assays are performed simultaneously in random access mode. The system’s unique method of sample management offers high throughput and rapid processing of STAT samples without interrupting ongoing testing. Along with our patented viscosity-based detection system (VDS™) technology and implementation of Windows XP® * software, the STA-R Evolution® Expert Series incorporates features such as QC commenting, enhanced traceability and various export formats. Analyzer is provided with: 17 inch LCD touch screen flat panel monitor Color printer, printer stand and keyboard Operator’s manual Accessory kit 1-year warranty Dimensions Height . . . . . . . . . . . 49.2 inches Width . . . . . . . . . . . . 50.3 inches Depth . . . . . . . . . . . . 32.2 inches Weight . . . . . . . . . . . 564 pounds Test Selections 200 user definable tests Samples 215 on-board sample capacity Primary tube sampling 5 samples per rack Continuous sample access LIS Interface Bi-directional host-query Automation Compatible with all major automation vendors STA-R Evolution® Expert Series *Windows XP is a trademark of Microsoft Corporation. 3 Section. 1 Instruments CAT. NO. (CONTINUED) PRODUCT / DESCRIPTION 58990 STA Compact Max ® Coagulation System Fully Automated, Medium-Throughput Hemostasis Analyzer 58989 STA Compact Max ® Coagulation System Cap Piercing Model Fully Automated, Medium-Throughput Hemostasis Analyzer The STA Compact Max® is a fully automated, benchtop 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 without the need to interrupt current testing. 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 state of the art data automation with the Expert Module software. The combination of VDS methodology and the Expert Module on the STA Compact Max ® give you complete confidence in the most important part of any analyzer: “The Results”. Analyzer is provided with: Expert Module Computer and Software 22 inch color touch screen Laser printer Uninterruptible power supply Operator’s reference manual Accessory kit 1-year warranty Dimensions Height . . . . . . . . . . . 27,75 inches Width . . . . . . . . . . . 38.18 inches Depth . . . . . . . . . . . 28.73 inches Weight . . . . . . . . . . 309 pounds Test Selections 80 user definable tests Samples 96 primary sample tubes onboard - 84 positions for primary tubes - 12 positions for pediatric tubes Continuous sample access True STAT Managment without hout impact on throughput ion Postive barcode identification LIS Interface Bi-directional host-query orr Dynamic Download STA Compact Max ® 4 Section. s Instruments CAT. NO. 58104 1 (CONTINUED) PRODUCT / DESCRIPTION STA Satellite® Hemostasis System 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 Integrated Health Networks to standardize patient testing results, including D-Dimer and Anti-Xa. The STA Satellite® offers technological advances to ensure a high level of system reliability, as well as ease of use and flexibility. Analyzer is provided with: Accessory kit Operator’s reference manual 1-year warranty Dimensions . . . Height . . . . . . . . . . . 27.4 inches Width . . . . . . . . . . . 21.1 inches Depth . . . . . . . . . . . 25. 5 inches Weight . . . . . . . . . . 72 pounds Test Selections 80 user definable tests Samples 20 on-board sample capacity Primary tube sampling Removable sample carousel Continuous sample loading Positive sample identification LIS Interface Bi-directional host-query Other Features Light-emitting diode (LED) for colorimetric assays Internal barcode reader for samples and reagents Patented viscosity-based detection system for standard VDS™ Mechnical Clot Detection. Reagent Menu PT APTT Fibrinogen AT Heparin (UFH and LMWH) D-dimer STA Satellite® 5 Section 1 Instruments CAT. NO. 58230 (CONTINUED) PRODUCT / DESCRIPTION ® STart Hemostasis Analyzer Benchtop Hemostasis Analyzer for Batch Testing The STart® is a benchtop hemostasis analyzer featuring Stago’s patented 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 . . . . . . . . . . . 4.7 inches Width . . . . . . . . . . . 16.1 inches Depth . . . . . . . . . . . 16.5 inches Weight . . . . . . . . . . 12.5 pounds Methodology Clotting – Standard VDS™ Mechanical Clot Detection Test Selections 17 test selections Preprogrammed and programmable options Other Features Electronically-linked multiple pipettor for convenience and accuracy Internal thermal 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) 6 STart® Section. s 2 Disposables and Accessories CAT. NO. PRODUCT / DESCRIPTION CONTENTS STA-R Evolution®, STA Compact ® and STA Satellite® Disposables and Accessories 00741 STA®-Microtainers (for samples) 500 each 00797 STA®-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 ®) 27421 Suction Tip 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 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 39163 Suction Tip 2 each (STA-R) 39164 Needle # 1 Cap Piercing 1 each (STA-R) 39249 Needle # 1 1 each (STA-R) 39250 Needle # 2 1 each (STA-R) ® 7 Section 2 Disposables and Accessories CAT. NO. PRODUCT / DESCRIPTION (CONTINUED) CONTENTS STA-R Evolution®, STA Compact ® and STA Satellite® Disposables and Accessories (continued) 39356 Needle Equipped 1 each (STA Satellite®) 39430 STA® Satellite Cuvettes 6 x 220 (STA Satellite®) 39593 Reducer DIN 14 2 each (STA Satellite®) 39899 Reagent Carousel 1 each (STA Satellite®) 39902 Sample Carousel 1 each (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 STart ® Disposables and 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 27577 Fuse 0.5 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 Section 3 Screening Tests CAT. NO. PRODUCT / DESCRIPTION CONTENTS 00605* STA® - Neoplastine ® CI 5 Determination of Prothrombin Time (PT) by STA® analyzers (ISI~1.8). Freeze-dried rabbit brain thromboplastin with heparin inhibitor. 6 x 5 mL vials of STA® Neoplastine® CI 5 6 x 5 mL vials of Solvent 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. 6 x 5 mL vials of STA® Neoplastine® CI Plus 5 6 x 5 mL vials of Solvent 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. 12 x 10 mL vials of STA® Neoplastine® CI Plus 10 12 x 10 mL vials of Solvent 00595US STA® - PTT Automate 5 Determination of Activated Partial Thromboplastin Time (APTT) by STA® analyzers. Cephalin reagent with particulate (silica) activator. 12 x 5 mL vials 00674US STA® - Fibrinogen 5 Quantitative determination of Fibrinogen by STA® analyzers (Clauss Method). Freeze-dried human thrombin (~80 NIH units/mL) with heparin inhibitor and calcium. 12 x 5 mL vials 00611 STA® - Thrombin 2 Determination of Thrombin Time by STA® analyzers. Freeze-dried human thrombin (1.5 NIH units/mL) with calcium. 12 x 2 mL vials 00669 STA® - Thrombin 10 Determination of Thrombin Time by STA® analyzers. Freeze-dried human thrombin (1.5 NIH units/mL) with calcium. 12 x 10 mL vials 00597 STA® - C.K. Prest ® 5 Determination of Activated Partial Thromboplastin Time (APTT) by STA® analyzers. Cephalin reagent with kaolin activator. 6 x 5 mL vials of STA® C.K. Prest® 5 6 x 5 mL vials of Activator 00614 STA® - Reptilase ® Determination of Reptilase® Time. Extracted venom of Bothrops atrox, ~20 BU (Batroxobin unit) per vial. 6 x 2 mL vials * ISI values for PT reagents are approximations. Actual ISI values are assigned for each lot of PT reagent. 10 Section. s 4 Factor Assays CAT. NO. PRODUCT / DESCRIPTION CONTENTS 00722 STA® - Deficient XII Substrate plasma for Factor XII assay by STA® analyzers. Freeze-dried human plasma lacking Factor XII. 6 x 1 mL vials 00723 STA® - Deficient XI Substrate plasma for Factor XI assay by STA® analyzers. Freeze-dried human plasma lacking Factor XI. 6 x 1 mL vials 00724 STA® - Deficient IX Substrate plasma for Factor IX assay by STA® analyzers. Freeze-dried human plasma from which Factor IX has been removed by selective immuno-adsorption. 6 x 1 mL vials 00725 STA® - Deficient VIII Substrate plasma for Factor VIII assay by STA® analyzers. Freeze-dried human plasma from which Factor VIII has been removed by selective immuno-adsorption. 6 x 1 mL vials 00738 STA® - Deficient X Substrate plasma for Factor X assay by STA® analyzers. Freeze-dried human plasma from which Factor X has been removed by selective immuno-adsorption. 6 x 1 mL vials 00743 STA® - Deficient VII Substrate plasma for Factor VII assay by STA® analyzers. Freeze-dried human plasma from which Factor VII has been removed by selective immuno-adsorption. 6 x 1 mL vials 00744 STA® - Deficient V Substrate plasma for Factor V assay by STA® analyzers. Freeze-dried human plasma, artificially depleted of Factor V. 6 x 1 mL vials 00745 STA® - Deficient II 6 x 1 mL vials 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 Asserachrom® IX:Ag Enzyme immunoassay of Factor IX Antigen by ELISA method, 96 tests. 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 s . 11 Section 5 Anticoagulants CAT. NO. PRODUCT / DESCRIPTION CONTENTS Heparin Anti-Xa Chromogenic Assays 00311US STA® Liquid Anti-Xa 4 - NEW 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 competive assay by STA® analyzers. 6 x 4 mL vials of Reagent 1 (Substrate) 6 x 4 mL vials of Reagent 2 (F. Xa) 00322US STA® Liquid Anti-Xa 8 - NEW 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 competive assay by STA® analyzers. 6 x 8 mL vials of Reagent 1 (Substrate) 6 x 8 mL vials of Reagent 2 (F. Xa) 00906 4 x 2 mL vials of AT III 2 x 15 mL vials of Buffer 4 x 4 mL vials of F. Xa 4 x 4 mL vials of Substrate Stachrom® Heparin Colorimetric assay of unfractionated and low molecular weight heparins. Lyophilized chromogenic substrate CBS 31.39, purified bovine AT III, purified bovine Factor Xa, Tris buffer. Heparin Induced Thrombocytopenia (HIT) 00615 Asserachrom® HPIA (ELISA) Determination of anti-heparin-PF4 antibodies by ELISA method, 48 tests. 3 x 2 Coated Strips 6 x 2 mL vials of Anti-IgG,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 Section 6 Thrombophilia CAT. NO. PRODUCT / DESCRIPTION CONTENTS Inhibitors 12 00516 STA® - Liatest ® Free Protein S Immuno-turbidimetric assay for Free protein S Antigen by STA® analyzers. Suspension of microparticles coated with monoclonal antibodies to Free Protein S. 6 x 5 mL vials of Buffer 6 x 6 mL vials of Latex 00568 Liatest ® AT III Immuno-turbidimetric assay for Antithrombin Antigen. Suspension of microlatex particles coated with rabbit anti-human AT antibodies. 6 x 1 mL vials of Latex 6 x 4 mL vials of Buffer 00570 Liatest ® Protein S Immuno-turbidimetric assay for Total Protein S Antigen. Suspension of microlatex particles coated with rabbit anti-human total protein S antibodies. 6 x 1 mL vials of Latex 6 x 4 mL vials of Buffer Section. s Thrombophilia CAT. NO. 6 (CONTINUED) PRODUCT / DESCRIPTION CONTENTS 00596 STA® - Stachrom ® AT III Colorimetric assay of Antithrombin activity by STA® analyzers. Bovine thrombin ~11.3 nKat/mL, freeze-dried. 4 x 3 mL vials of Thrombin 4 x 3 mL vials of Substrate 4 x 3 mL vials of Thrombin Solvent 00671 STA® - Stachrom® Protein C Colorimetric 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 substate CBS 42.46 of ~15 μmoles/vial. 6 x 3 mL vials of PC-Activator 6 x 3 mL vials of Substrate 00746 STA® - Staclot ® Protein S 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. 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 00747 STA® - Staclot ® Protein C Clotting assay of Protein C activity by 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. 3 x 1 mL vials of Protein C Deficient Plasma 3 x 1 mL vials of PC-Activator 00944 Asserachrom® Protein C Enzyme immunoassay for Protein C Antigen by ELISA method, 96 tests. 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 bottle of Washing Solution 3 x 0.5 mL vials of Protein C Calibrator 3 x 0.5 mL vials of Protein C Control 1 Plate Frame; 1 Plate Cover 00945 Asserachrom® Total Protein S One-step enzyme immunoassay for Total Protein S Antigen by ELISA method, 96 tests. 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 bottle of Washing Solution 3 x 0.5 mL vials of Total Protein S Calibrator 3 x 0.5 mL vials of Total Protein S Control 1 Plate Frame; 1 Plate Cover 00946 Asserachrom® Free Protein S One-step enzyme immunoassay for Free Protein S Antigen by ELISA method, 96 tests. 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 bottle of Washing Solution 3 x 0.5 mL vials of Free Protein S Calibrator 3 x 0.5 mL vials of Free Protein S Control 1 Plate Frame; 1 Plate Cover 13 Section 6 Thrombophilia CAT. NO. (CONTINUED) PRODUCT / DESCRIPTION CONTENTS Lupus Anticoagulants 14 00339 STA® - Staclot ® DRVV Screen 2 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. 12 x 2 mL vials 00333 STA® - Staclot ® DRVV Screen 5 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. 12 x 5 mL vials 00334 STA® - Staclot ® DRVV Confirm 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. 12 x 2 mL vials 00600 Staclot ® LA 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. 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 00594 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 00599 PTT-LA (LA Screen) Lupus Anticoagulantsensitive APTT reagent. Cephalin reagent with particulate activator (silica), freeze-dried. 6 x 2 mL vials Section. s Fibrin Formation and Degradation CAT. NO. PRODUCT / DESCRIPTION CONTENTS 00515 STA® - Liatest ® D-Di Immuno-turbidimetric assay of D-dimer by STA® analyzers. Microlatex particles coated with two different mouse monoclonal anti-human D-dimer antibodies. 6 x 5 mL vials of Buffer 6 x 6 mL vials of Latex 00947 Asserachrom® D-Di Enzyme immunoassay of D-dimer by ELISA method, 96 tests. 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 00454 D-Di Test ® Latex aggultination slide test for the qualitative and semi-quantitative determination of D-dimer in plasma, 60 tests. 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 00548 F.S./FDP Plasma Test Cards For use with catalog #00540 and #00887. 10 - cards 00887 F.S. Test Unit Stat detection of soluble fibrin monomer complexes by hemagglutination, 32 tests. 8 x 0.2 mL vials of F.S. Test Unit Reagent 8 x 0.2 mL vials of Positive Control 8 x 0.2 mL vials of Negative Control 10 - Test Cards 00857 F.S. Test Batch detection of soluble fibrin monomer complexes by hemagglutination, 40 tests. 4 x 0.5 mL vials of F.S. Test Reagent 4 x 0.5 mL vials of Positive Control 4 x 0.5 mL vials of Negative Control 7 s . 15 Section 8 Fibrinolysis CAT. NO. PRODUCT / DESCRIPTION CONTENTS 00658 STA® - Stachrom® Plasminogen Colorimetric assay of plasminogen activity by STA® analyzers. 6 x 3 mL vials of Streptokinase 6 x 3 mL vials of Substrate 00659 STA® - Stachrom® Antiplasmin Colorimetric assay of antiplasmin activity by STA® analyzers. 4 x 2 mL vials of Plasmin 4 x 6 mL vials of Substrate 4 x 2 mL vials of Plasmin Solvent 00948 Asserachrom® tPA Enzyme immunoassay of tissue plasminogen activator antigen by ELISA method, 96 tests. 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 Adhesive Films Section 9 16 Primary Hemostasis CAT. NO. PRODUCT / DESCRIPTION CONTENTS 00518 STA® - Liatest ® VWF:Ag Immuno-turbidimetric assay of Von Willebrand Factor (VWF:Ag) Antigen by STA ® analyzers. Microlatex particles coated with rabbit anti-human VWF antibodies. 4 x 5 mL vials of Buffer 4 x 2 mL vials of Latex 4 x 4 mL vials of Latex Diluent 00942 Asserachrom ® VWF:Ag Enzyme immunoassay of Von Willebrand Factor Antigen by ELISA method, 96 tests. 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 00950 Asserachrom® β-TG Enzyme immunoassay for β -Thromboglobulin Antigen by ELISA method, 96 tests. 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 00951 Asserachrom® PF4 Enzyme immunoassay for Platelet Factor 4 Antigen by ELISA method, 96 tests. 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 Section. s 10 Control Plasmas CAT. NO. PRODUCT / DESCRIPTION CONTENTS 00381 STA® - Quality HNF/UFH - NEW Control plasma for assay of unfractionated heparin (UFH) ® using the STA Liquid Anti-Xa method on STA analyzers. 6 x 1 mL vials of STA ® Quality HNF/UFH 2 6 x 1 mL vials of STA ® Quality HNF/UFH 5 00676 STA® - Coag Control N + ABN Multi-constituent normal and abnormal plasma controls for routine assays performed on the STA® family of hemostasis analyzers. 12 x 1 mL vials of STA® Coag Control N 12 x 1 mL vials of STA® Coag Control ABN 00678 STA® - System Control N + P Multi-constituent normal and abnormal plasma controls for routine and specialty assays performed on the STA® family of hemostasis analyzers. 12 x 1 mL vials of STA® System Control N 12 x 1 mL vials of STA® System Control P 00526US STA® - Liatest ® Control N + P 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). 12 x 1 mL vials of STA® Liatest® Control N 12 x 1 mL vials of STA® Liatest® Control P 00683 STA® - Heparin Control Control plasma for assays of unfractionated heparins (UFH) using the Anti-Xa method on STA® analyzers. 6 x 1 mL vials of STA® Heparin Control 2 6 x 1 mL vials of STA® Heparin Control 5 00686 STA® - Quality HBPM/LMWH Control plasma for assays of low molecular weight heparins (LMWH) using the Anti-Xa method on STA® analyzers. 6 x1mL vials of STA® Quality HBPM/LMWH Control 8 6 x1 mL vials of STA® Quality HBPM/LMWH Control14 00201 STA® - Control LA 1 + 2 Control plasmas for lupus anticoagulant (LA) detection. 3 x 1 mL vials of STA® Control LA 1 3 x 1 mL vials of STA® Control LA 2 Section. s 11 Calibrators CAT. NO. PRODUCT / DESCRIPTION CONTENTS 00348 STA® - Multi Hep Calibrators - NEW Calibration plasmas for both UFH and LMWH using the STA ® Liquid Anti-Xa method on the STA® analyzers. 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 00684 STA® - Hepanorm® H Calibration plasmas for assays of unfractionated heparin (UFH) using the Anti-Xa method on STA® analyzers. 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 00685 STA® - Calibrator HBPM/LMWH Calibration plasmas for assays of low molecular weight heparins (LMWH) using the Anti-Xa method on STA® analyzers. 4 x 1 mL vials of STA® Calibrator HBPM/LMWH 0 4 x 1 mL vials of STA® Calibrator HBPM/LMWH 9 4 x 1 mL vials of STA® Calibrator HBPM/LMWH 18 00520 STA® - VWF:Ag Calibrator 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). 6 x 1 mL vials 00675 STA® - Unicalibrator Multi-constituent calibration plasma for functional assays of coagulation parameters on STA® analyzers. 6 x 1 mL vials 17 Section 12 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® - CaCl 2 0.025M 24 x 15 mL 00555 Asserachrom 00973 STA® - Cleaner Solution 00975US 18 ® ® Washing Solution STA - Desorb U 2 x 50 mL 6 x 2.5 L 24 x 15 mL Section. s External Quality Assessment Program CAT. NO. PRODUCT / DESCRIPTION 13 CONTENTS Qualiris by Stago is a new 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. Basic Programs 01044 Qualiris QC Premium S1 Monthly external quality assessment of PT, APTT, Fibrinogen, Thrombin Time 12 x 1 mL 01045 Qualiris QC Premium S2 Monthly external quality assessment of PT, APTT, Fibrinogen, Thrombin Time 12 x 1 mL 01046 Qualiris QC Experience Twice per year external quality assessment of PT, APTT, Fibrinogen, Thrombin Time 6 x 1 mL . Optional Add-On Programs 85093 Qualiris QC Premium Factors External quality assessment of Factors II, V, VII, VIII, IX, X, XI, XII, & VWF 85094 Qualiris QC Premium Thrombophilia External quality assessment of Antithrombin, Protein C, Protein S, Plasminogen, Antiplasmin 85098 Qualiris QC Experience Factors External quality assessment of Factors II, V, VII, VIII, IX, X, XI, XII, & VWF 85099 Qualiris QC Experience Thrombophilia External quality assessment of Antithrombin, Protein C, Protein S, Plasminogen, Antiplasmin 85145 Clarity, Peer Group Program for Stago Customers The Clarity Peer group offers an easy way to manage your lab’s quality control as compared to your peers who are using the same materials and lot numbers. Clarity offers: • Patented error-checking software to ensure a clean data pool • Custom peer groups for your organization as it relates to the peer group • On-demand report access with multiple report formats • Multiple data entry methods • Personalized, password protected web portal 01047 Qualiris QC Heparin HBPM / LMWH External quality assessment of low molecular weight heparins 6 x 1 mL 01048 Qualiris QC Heparin HNF / UFH External quality assessment of unfractionated heparin 6 x 1 mL 01049 Qualiris D-dimer External quality assessment of D-dimer 6 x 1 mL 01050 Qualiris Diagnostic Challenge Unique continuing education program with unassayed samples and a Clinical Case History 3 Cases / year 6 x 1 mL s 19 Section 14 TM Stago Added Value on Request (SAVOR ) As the Hemostasis market matures, it is characterized by consolidation, automation and an overall shortage of medical technologists - those who perform the actual work in the lab. Specialists have become generalists, and employee turnover is high. While the laboratory is evolving, the demand for knowledge and expertise is greater than ever. SAVORTM (Stago Added Value on Request) is an evolution of our current offerings, customized to meet our customers’ requests for tailored training programs, inventory management and other services. In addition to new programs, we have evaluated our existing training and modified our approach to provide a more “hands-on” experience. Our objective is for the lead technologist/key operator to leave the program with a higher level of expertise. As always, premium service and customer satisfaction remain our highest priority as we adapt our offerings to a changing laboratory environment. Please use this section of our catalog as a guide to our expanding service and support offerings. Each item includes a reference catalog number and detailed description. Your Stago Account Manager can provide additional details related to logistics and pricing. Basic Operator Training Hospitals or laboratories that a purchase a new Stago instrument are entitled to training at our Parsippany, New Jersey, training facility. The length of the program depends on the instrument purchased. The Basic Operator Training course is available for the newly designated “lead technologist” or “key operator” of Stago instruments or when there is a need to have additional personnel (beyond contract specifications) receive the training. Price includes transportation, hotel, meals and training manuals. ITEM# INSTRUMENT COURSE DESCRIPTION 08416 Compact In-house Basic Operator Training - Compact DAYS 2.5 Following the completion of this course, participants will be able to: - Recognize analyzeer hardware - Prepare and load consumables/reagents - Complete practice runs included in the training manual - Understand the software - Perform user maintenance functions on the analyzer - Perform method validation/lot conversion ITEM# INSTRUMENT COURSE DESCRIPTION 08417 Evolution In-house Basic Operator Training - Evolution Following the completion of this course, participants will be able to: - Recognize analyzeer hardware - Prepare and load consumables/reagents - Load patient samples on the analyzer and order tests - Complete practice runs included in the training manual - Understand the software - Perform user maintenance functions on the analyzer - Perform method validation/lot conversion 20 DAYS 4.0 Section. s TM Stago Added Value on Request (SAVOR ) cont. 14 On-site Basic Operator Training Key Operator Training, on-site: The Basic Operator Training course is offered to customers who cannot attend training at the Parsippany, New Jersey, training facility. A member of the Stago Training Team will be assigned to visit the laboratory and conduct the Basic Operator Training. ITEM# INSTRUMENT COURSE DESCRIPTION 08419 Compact On-site Basic Operator Training - Compact DAYS 2 Following the completion of this course, participants will be able to: - Recognize analyzeer hardware - Prepare and load consumables/reagents - Load patient samples on the analyzer and order tests - Complete practice runs included in the training manual - Understand the software - Perform user maintenance functions on the analyzer - Perform method validation/lot conversion ITEM# INSTRUMENT 08420 Evolution COURSE DESCRIPTION On-site Basic Operator Training - Evolution DAYS 3 Following the completion of this course, participants will be able to: - Recognize analyzeer hardware - Prepare and load consumables/reagents - Load patient samples on the analyzer and order tests - Practice loading patient samples on the analyzer and order tests - Complete practice runs included in the training manual - Understand the software - Perform user maintenance functions on the analyzer - Perform method validation/lot conversion ITEM# INSTRUMENT COURSE DESCRIPTION 08418 Calibrated Automated Thrombogram On-site Basic Operator Training - CAT DAYS 1 Following the completion of this course, participants will be able to: - Installation of analyzer - Demonstration of reagent preparation - Demonstration of use and application of Thrombinoscope software - Practice measurement and data analysis - Review of available reagents and potential applications 21 Section 14 TM Stago Added Value on Request (SAVOR ) cont. Experienced Operator Training (Rollover, Software Upgrade): The Experienced Operator Training course is designed for institutions that have been using Stago’s instrument and are replacing their existing instrument with the same or similar model. Experienced Operator Training is typically conducted by members of the Field Support Group at the customer’s facility. ITEM# INSTRUMENT COURSE DESCRIPTION 08421 Compact Experienced Operator Training - Compact DAYS 1 day 4 hours/class 3 Techs/class This condensed class builds on skills learned in the Basic Course. Following the Completion of this course, participants will: - Recognize hardware areas on the analyzer - Understand the software - Perform user maintenance functions on the analyzer - Possess advanced troubleshooting skills - Possess advanced technical knowledge ITEM# INSTRUMENT COURSE DESCRIPTION 08422 Evolution Experienced Operator Training - Evolution 1.5 days 4 hours/class DAYS 3 Techs/class This condensed class builds on skills learned in the Basic Course. Following the Completion of this course, participants will: - Recognize hardware areas on the analyzer - Understand the software - Perform user maintenance functions on the analyzer - Possess advanced troubleshooting skills - Possess advanced technical knowledge Advanced Operator Training Advanced Operator Training is designed as an advanced troubleshooting program. The course is conducted by a member of the Stago Training Team at the customer’s facility. ITEM# INSTRUMENT COURSE DESCRIPTION 08423 Compact Advanced Operator Training - Compact DAYS 2 days 4 hours/class up to 2 classes/day 2 Techs/class This class builds on skills learned in the Basic Course. It is designed based on customer needs. Following the Completion of this course, participants will: - Possess advanced troubleshooting skills - Possess advanced technical knowledge ITEM# INSTRUMENT COURSE DESCRIPTION 08424 Evolution Advanced Operator Training - Evolution 2 days 6 hours/class 3 Techs/class This class builds on skills learned in the Basic Course. It is designed based on customer needs. Following the Completion of this course, participants will: - Possess advanced troubleshooting skills - Possess advanced technical skills 22 Section. s TM Stago Added Value on Request (SAVOR ) cont. 14 Reagent Application Technical Support The Stago Technical Support Specialist will assist with adding a test parameter to a Stago or non-Stago coagulation instrument. Assistance could include test set-up, method validation, running test samples, and data collection and analysis. ITEM# SERVICE DESCRIPTION 08427 On-Site Technical Assistance Stago Inventory Management Stago receives many requests for customized inventory management solutions, including the sequestering of products that typically would not be sequestered. The nominal fee is to offset the cost of financing inventory, storage for extended periods and multiple shipments. Requirements include: - hard copy purchase order with specified quantity - shipping schedule including beginning and end dates ITEM# SERVICE DESCRIPTION 08431 Inventory Management and Shipping Lab Automation The 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. ITEM# ACCESSORIES 80200 Beckman Line Line Kit and Platform 80138 Beckman Line Ramp and Adjustment System 80140 Beckman Line Platform Foot Assembly (may not be necessary) 80201 Bayer Line Kit and Platform 80210 Bayer Ramp and Adjustment System 88517 Labotix Connection Kit 88541 Labotix Ramp & adjustment System 23 Section 14 TM Stago Added Value on Request (SAVOR ) cont. Advanced Training Workshop Instrument Workshop: 1 full day The program is customized to meet the needs of the particular audience. The agenda is composed of a lecture component and hands-on instrument demonstrations. The specific topics are determined by the participants prior to the event. PACE credits available. ITEM# COURSE DESCRIPTION 08432 Advanced Training Workshop Method Validation Standard Service. Stago's standard is to provide customers with in-depth training and tools to perform method validation as part of our new instrument training program. In this case, your Stago Technical Support Specialist is available via telephone support to review the protocol, answer questions and provide a final data review. SAVOR Method Validation Service. We realize that some customers, due to staffing shortages and/or convenience, would prefer to have a Stago Technical Support Specialist on-site to coordinate and perform method validation. In this case, the Technical Support Specialist will run the tests, collect data, perform data analysis and provide an electronic data presentation. ITEM# DAYS OF ON-SITE SUPPORT SERVICE DESCRIPTION 08428 3 Routine Assays: PT, APTT, Fib, TT, D-dimer 08429 4 Routine + Specialty Assays ITEM# DESCRIPTION 82041 Method Validation Binder (paper report) Lot Conversion Lot Conversion/Simple Method Validation (usually a single test parameter) Lot Conversion. We realize that some customers, due to staffing shortages and/or convenience, would prefer to have a Stago Technical Support Specialist on-site to perform lot conversion. In this case, 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 at your hospital 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. ITEM# 08430 24 DAYS OF ON-SITE SUPPORT 1 SERVICE DESCRIPTION Routine Assay Lot Conversion Section. s TM Stago Added Value on Request (SAVOR ) cont. 14 Preventive Maintenance on Demand Preventive Maintenance on Demand is designed for those customers who have a backup instrument that does not include a full-service contract. Based on a customer request, 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. ITEM# INSTRUMENT SERVICE DESCRIPTION 85075 Compact Preventative Maintenance - Compact 85076 Evolution Preventative Maintenance - Evolution Instrument Decommission A Stago Field Service Engineer will decontaminate your retired coagulation instrument and remove the hard drive in compliance with regulatory and HIPAA requirements. This program applies to Stago manufactured instruments only and is performed while the Stago Field Service Engineer in on-site for another reason. ITEM# SERVICE DESCRIPTION 85077 Decommission 85078 Decommission and return instrument to Stago for disposal 85079 Special visit to perform decommission procedure Lot Conversion Analysis A Stago Technical Support Specialist (TSS) will receive data generated by the lab via email, fax or other means. The Technical Support Specialist then loads the data into the appropriate template, reviews data for outliers, and provides a report back to the customer. The TSS is not on-site at the lab during the data generation process. ITEM# SERVICE DESCRIPTION 08434 TSS Assistance: Lot Conversion Analysis 25 Section 15 Thrombin Generation Research Products (Research Use only, not for diagnostic procedures) CAT. NO. PRODUCT / DESCRIPTION CONTENTS Instrument 86186 Calibrated Automated Thrombogram® The Calibrated Automated Thrombogram ® (CAT) measures the concentration of thrombin generation 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. Thermo Electron Fluoroskan Ascent Analyzer Computer Thrombinoscope Software Operator’s reference manual Dongle Filters: 1 – 390nm, 1– 460nm Reagents 86192 Thrombin Calibrator Corrects for individual differences in color of plasma, inner filter effect and substrate consumption, which is necessary for use in parallel with each sample. 20 x 16 tests 86193 PPP Reagent Used with platelet poor plasma for general applications using the CAT System. 20 x 16 tests 86194 PPP Reagent Low Used with platelet poor plasma and have a high sensitivity to Factors VIII, IX and XI. Thus, this reagent increases sensitivity in hemophiliac plasma. 20 x 16 tests 86195 PPP Reagent High Used with platelet poor plasma when thrombin generation is strongly inhibited. Thus, this reagent increases sensitivity in plasmas containing anticoagulants such as heparin. 20 x 16 tests 86196 PRP Reagent Used with platelet rich plasma to initiate thrombin generation. PRP-Reagent can also be used in platelet-poor plasma to determine the existence of and examine the phospholipidic activity of microparticles. 20 x 16 tests 86197 FluCa Kit Specific fluorogenic substrate and buffer suitable for thrombin generation necessary for each experiment. 10 x 16 tests 86222 MP Reagent Used with platelet free plasma and is specifically sensitive to circulating Tissue Factor present on the surface of procoagulant microparticles. 20 x 16 tests Disposables 86175 26 Immulon Round Bottom plate, 2HB 50/box Section s Ecarin Chromogenic Assay (ECA) Products (Research Use only, not for diagnostic procedures) 16 CAT. NO. PRODUCT / DESCRIPTION CONTENTS 01051 ECA-H Quantitative determination of hirudin concentrations in plasma samples by the Ecarin Chromogenic Assay (ECA) method, 85 tests. 2 x 6 mL ECA Prothrombin Buffer 1 x 3 mL ECA-H Substrate 2 x 3 mL Ecarin Reagent 1 x 3 mL ECA-H Calibrator 0 μg/mL 1 x 2 mL ECA-H Calibrator 2 μg/mL Hirudin 1 x 2 mL ECA-H Control 1 μg/mL Hirudin 01052 ECA-T Quantitative determination of synthetic direct thrombin inhibitors (DTI) by the Ecarin Chromogenic Assay (ECA) method, 85 tests. 2 x 6 mL ECA Prothrombin Buffer 1 x 3 mL ECA-T Substrate 2 x 3 mL Ecarin Reagent 1 x 2 mL ECA-T Calibrator 0 μg/mL 1 x 1 mL ECA-T Calibrator 1.2 μg/mL Synthetic Direct Thrombin Inhibitor 1 x 2 mL ECA-T Control 0.6 μg/mL Synthetic Direct Thrombin Inhibitor 01053 ECA Hirudin Control Hirudin Control for ECA-H kit. 3 x 2 mL ECA-H Control (0.9 μg/mL - 1.1 μg/mL) 01054 ECA Argatroban Standards Argatroban Calibrator for the ECA-T kit. 3 x 2 mL ECA-T Calibrator 0 μg/mL 3 x 2 mL ECA-T Argatroban Calibrator 3 μg/mL 01055 ECA Argatroban Control Argatroban Control for the ECA-T kit. 3 x 2 mL ECA-T Control Argatroban Low (0.4 μg/mL 0.6 μg/mL) 3 x 2 mL ECA-T Control Argatroban High (1.7 μg/mL 2.3 μg/mL) 01056 ECA Bivalirudun Standards Bivalirudin Calibrator for the ECA-T kit. 3 x 2 mL ECA-T Calibrator 0 μg/mL 3 x 2 mL ECA-T Bivalirudin Calibrator 20 μg/mL 01057 ECA Bivalirudun Control Bivalirudin Control for the ECA-T kit. 3 x 2 mL ECA-T Control Bivalirudin 10 μg/mL (8.6 μg/mL 11.4 μg/mL) 27 Section. s Flow Cytometry Research Products (Research Use only, not for diagnostic procedures) CAT. NO. PRODUCT / DESCRIPTION 17 CONTENTS Flow Cytometry research kits from BioCytex 00111 Platelet GP Receptors 5 tests PLT Gp/Receptors kit allows precise quantitation of GpIIb, GpIbα and GMP140 glycoproteins on platelet surface, at 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. 00419 Platelet HPA1 kit 10 tests For analysis of a a platelet glycoprotein polymorphism in the HPA system (Human Platelet Antigens). 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). 29 Section 17 Flow Cytometry Research Products (CONTINUED) (Research Use only, not for diagnostic procedures) CAT. NO. PRODUCT / DESCRIPTION CONTENTS Monoclonal antibodies for flow cytometry from BioCytex 30 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, clone4F8, 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 Section . s Flow Cytometry Research Products (CONTINUED) (Research Use only, not for diagnostic procedures) CAT. NO. PRODUCT / DESCRIPTION 17 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 01077 Megamix-Plus FSC 50 tests 01078 Megamix-Plus SSC 50 tests s Section 18 Research Kits CAT. NO. PRODUCT / DESCRIPTION CONTENTS (Research Use only, not for diagnostic procedures) 00180 Asserachrom® Protein Z Quantitative determination of Protein Z by ELISA method, 96 tests. 6 x 16 Coated Strips 3 x 8 mL vials of Anti-Protein Z-Peroxidase 6 tablets of Ortho-Phenylenediamine 6 tablets of Urea Peroxide 1 x 20 mL bottle of Dilution Buffer 1 x 50 mL bottle of Washing Solution 3 x 2 mL vials of Reference Plasma 1 Plate Frame; 1 Plate Cover 00241 Asserachrom® VII:Ag Quantitative determination of Factor VII:Ag by ELISA method, 96 tests. 3 x 2 Coated Strips 3 x 8 mL vials of Anti-VII:Ag-Peroxidase 6 tablets of Ortho-Phenylenediamine 6 tablets of Urea Peroxide 1 x 20 mL bottle of Dilution Buffer 1 x 50 mL bottle of 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 00243 Asserachrom® X:Ag Quantitative determination of Factor X:Ag by ELISA method, 96 tests. 3 x 2 Coated Strips 3 x 8 mL vials of Anti-X:Ag-Peroxidase 6 tablets of Ortho-Phenylenediamine 6 tablets of Urea Peroxide 1 x 20 mL bottle of Dilution Buffer 1 x 50 mL bottle of 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 31 Section 18 Research Kits (CONTINUED) (Research Use only, not for diagnostic procedures) CAT. NO. PRODUCT / DESCRIPTION CONTENTS 00261 Asserachrom® Total TFPI Quantitative determination of total Tissue Factor Pathway Inhibitor (TFPI) by ELISA method, 96 tests. 3 x 2 Coated Strips 3 x 2 mL vials of Anti-Total TFPI-Peroxidase 6 tablets of Ortho-Phenylenediamine 6 tablets of Urea Peroxide 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 00262 Asserachrom® Free TFPI Quantitative determination of free Tissue Factor Pathway Inhibitor (TFPI) by ELISA method, 96 tests. 3 x 2 Coated Strips 3 x 2 mL vials of Anti-Free TFPI-Peroxidase 6 tablets of Ortho-Phenylenediamine 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 β 00264 Asserachrom® sEPCR Quantitative determination of soluble Endothelial Protein C Receptor by ELISA method, 96 tests. 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 00265 Asserachrom® Anti-Prothrombin IgG,M Semi-quantitative determination of anti-prothrombin antibodies of IgG and/or IgM class by ELISA method, 96 tests. 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 00266 Asserachrom® APA Screen Qualitative detection of anti-phospholipid antibodies (APA) by ELISA method, 96 tests. 3 x 2 Coated Strips 3 x 8 mL vials of Anti-IgG,A,M-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 APA Screen Reference 3 x 2 mL vials of Control 1 3 x 2 mL vials of Control 2 1 Plate Frame; 1 Plate Cover 00267 Asserachrom® APA IgG,M Semi-quantitative determination of anti-phospholipid antibodies of IgG and/or IgM class by ELISA method, 96 tests. 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 APA IgG, IgM Calibrator 3 x 2 mL vials of APA Control 1 3 x 2 mL vials of APA Control 2 1 Plate Frame; 1 Plate Cover 32 Section. Research Kits 18 (CONTINUED) (Research Use only, not for diagnostic procedures) CAT. NO. PRODUCT / DESCRIPTION ® 00276 Asserachrom Soluble GPV Quantitative determination of soluble Glycoprotein V by ELISA method, 96 tests. 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 00280 Asserachrom® VIII:Ag Quantitative determination of Factor VIII Antigen by ELISA method, 96 tests. 3 x 2 Coated Strips 3 x 8 mL vials of Anti-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 00281 Staclot ® VIIa-rTF Clotting assay of activated Factor VII, 20 tests. 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 00346 STA® Stachrom® TAFI Quantitative determination of thrombin activable fibrinolysis inhibitor activity, Chromogenic Assay, 60 tests. 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 00429 STA® Procoag-PPL Clot-based assay for the detection of procoagulant phospholipids by STA® analysers, 60 tests. 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 00491 Asserachrom® Vlla-AT Quantitative determination of the FVlla-AT complex by ELISA method, 96 tests. 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 1 x 50 mL bottle of Washing Solution 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 ® ® 00543US STA Liatest FM Immuno-turbidimetric assay of Fibrin Monomer by STA® Monomer by STA ® analyzers. Microlatex particles coated with two different mouse monoclonal anti-human fibrin monomer antibodies, 90 tests. 6 x 2 mL vials of Buffer 6 x 4 mL vials of Latex 90 tests ® 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 ® 6 x 1 mL vials of control 1 6 x 1 mL vials of control 2 00544US STA FM Calibrator A set of calibrator plasmas intended for calibration of fibrin monomers present or not present in soluble complexes by the immunoturbidimetric method. 33 CONTENTS 00545US STA FM Control Two plasmas intended for the quality control of assays of fibrin monomers present or not present in soluble complexes by the immunoturbidimetric method Section 18 Research Kits (Research Use only, not for diagnostic procedures) CAT. NO. PRODUCT / DESCRIPTION CONTENTS 00581 Liatest ® C4b-BP Quantitative determination of C4b-BP by Immuno-turbidimetric measurement, 60 tests. 6 x 1 mL vials of Latex 6 x 4 mL vials of Buffer 00616 Asserachrom® TAFIa/TAFIai Quantitative determination of TAFIa/TAFIai by ELISA method, 96 tests 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 00631 Asserachrom® PIVKA-II Quantitative determination of PIVKA-II Antigen (DeCarboxy-Prothrombin) by ELISA method, 96 tests. 6 x 16 Coated Strips 3 x 8 mL vials of Anti-II-Peroxidase 6 tablets of Ortho-Phenylenediamine 6 tablets of Urea Peroxide 1 x 100 mL bottle of Dilution Buffer 1 x 50 mL bottle of Washing Solution 3 x 4 x 0.5 mL vials of Reference Plasma 1 Plate Frame; 1 Plate Cover ® 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 ® 3 x 1 mL vials of Control 1 3 x 1 mL vials of Control 2 00704US STA Rivaroxaban Calibrator Calibration plasmas for rivaroxaban measurement using chromogenic anti-Xa Method 00706US STA Rivaroxaban Control Control plasmas for rivaroxaban measurement using chromogenic anti-Xa Method 00851 Stachrom® Heparin Cofactor II Chromogenic assay of heparin cofactor II activity, 60 tests. 00853 Stachrom PAI Chromogenic assay of plasminogen activator inhibitor activity, 20 tests. ® 6 x 2 mL vials of Thrombin 6 x 2 mL vials of Substrate 1 x 15 mL bottle of Buffer 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 00949US Asserachrom ® PAI-1 Quantitative determination of plasminogen activator inhibitor-1 Antigen (PAI-1) by ELISA method, 96 tests. 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 00964 Purified Bovine Thrombin 50,000 NIH Units 01004 Cy-Quant CD146 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. 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 34 Section s 18 Research Kits(cont.) (Research Use only, not for diagnostic procedures) CAT. NO. PRODUCT / DESCRIPTION CONTENTS 01074 STA Apixaban Control 3 x 1 mL vials of Control 1 3 x 1 mL vials of Control 2 01075 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 01076 Cy-Quant VASP/P2Y12 Research Components 3 x 1 vial of Activator A (PGE1) 3 x 1 vial of Activator B (PGE1 + ADP) 3 x 2 strips of Anti-VASP coated strip 1 vial of Lysis buffer 1 vial of Washing solution 1 vial of Dilution buffer 1 vial of Anti VASP-P peroxidase 1 vial of TMB 1 vial of Stop solution 1 plate frame (Research Use only, not for diagnostic procedures) CAT. NO. PRODUCT / DESCRIPTION Purified Proteins CONTENTS a 00392 Purified β2-GP1 100 μg 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 Chromogenic Substrates 10 μg b 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 Inhibitors b 35 00361 Russell's Viper Venom (RVV) 1 vial, 0.4 mg of crude venom 00501 Ristocetin (for platelet aggregation) 1 x 100 mg vial 00820 Aprotinin (Kunitz Protease Inhibitor) 6 vials, each approximately 10 PEU, 1 PEU = 1,800 kallikrein inhibitor units (KIU) 00823 Ecarin 1 vial, 50 Ecarin Units (EU) 00830 r-Hirudin 1 vial, 2,000 r-Hirudin Antithrombin Units (ATU) a Purified proteins are freeze-dried and are from human sources. b All chromogenic substrates, venoms and inhibitors are freeze-dried. . Section s 19 s . Abbreviations ABBREVIATION NAME Į2-AP Alpha-2-Antiplasmin ACA Anticardiolipin Antibodies APA Antiphospholipid Antibody(ies) APC Activated Protein C APTT Activated Partial Thromboplastin Time AT Antithrombin AT:Act Antithrombin Activity AT:Ag Antithrombin Antigen CaCl2 Calcium Chloride DIC Disseminated Intravascular Coagulation ELISA Enzyme-Linked Immunosorbent Assay Fib Fibrinogen FDP Fibrinogen Degradation Products FII Factor II or Prothrombin FV Factor V FVII Factor VII FVIII Factor VIII FIX Factor IX FX Factor X FXI Factor XI FXII Factor XII FM Fibrin Monomer GPV Glycoprotein V ABBREVIATION NAME HBPM Héparines de bas poids moléculaire (French designation for LMWH) HPIA Heparin-PF4 Induced Antibodies LA Lupus Anticoagulants LMWH Low Molecular Weight Heparin N+ABN Normal and Abnormal N+P Normal and Pathologic OPD Ortho-phenylenediamine PAI 1 Plasminogen Activator Inhibitor 1 PC Protein C PF4 Platelet Factor 4 PIVKA Protein Induced by Vitamin K Antagonists PNP Pooled Normal Plasma PS Protein S PT Prothrombin Time PTT-LA LA Sensitive APTT TAFI Thrombin Activable Fibrinolysis Inhibitor TFPI Tissue Factor Pathway Inhibitor TMB Tetra Methyl Benzidine TT Thrombin Time UFH Unfractionated Heparin VWD Von Willebrand Disease VWF Von Willebrand Factor 36 Coagulation Cascade Terms and Conditions of Sale FOR REAGENTS, DISPOSABLES & ACCESSORIES Definitions: Sequestering: Products: 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. DSI: Customer: Reagents, Disposables and Accessories as defined in DSI's Product catalog in force from time to time. Diagnostica Stago, Inc., a Delaware corporation with its principal place of business at Five Century Drive, Parsippany, NJ 07054, the seller of the Products. The person or entity purchasing the Products. Ordering Information: Returns: 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 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. 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. 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: 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. 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. 38 Main Index Item Page(s) Asserachrom® Anti-β 2GP1 IgG. . . . . . . . . . . . . . . . . 32 Asserachrom® Anti-β 2GP1 IgM . . . . . . . . . . . . 32 Asserachrom® Anti-Prothrombin IgG, M . . . . . 32 Asserachrom® APA IgG, M . . . . . . . . . . . . . . . . 32 Asserachrom® APA Screen . . . . . . . . . . . . . . . . 32 Asserachrom® D-Di . . . . . . . . . . . . . . . . . . . . . . 15 Asserachrom® Free Protein S . . . . . . . . . . . . . . 13 Asserachrom® Free TFPI . . . . . . . . . . . . . . . . . 32 Asserachrom® PAl- 1 . . . . . . . . . . . . . . . . . . . . . 34 Asserachrom® PIVKA-II . . . . . . . . . . . . . . . . . . .34 Asserachrom® Protein C . . . . . . . . . . . . . . . . . . 13 . Asserachrom® Protein Z . . . . . . . . . . . . . . . . . . 31 Asserachrom® sEPCR . . . . . . . . . . . . . . . . . . . . 32 Asserachrom® Soluble GPV. . . . . . . . . . . . . . . . 33 Asserachrom® Thrombomodulin . . . . . . . . . . . 33 Asserachrom® Total Protein S . . . . . . . . . . . . . 13 Asserachrom® Total TFPI . . . . . . . . . . . . . . . . . 32 Asserachrom® tPA . . . . . . . . . . . . . . . . . . . . . . .16 Asserachrom® VII:Ag . . . . . . . . . . . . . . . . . . . . .31 Asserachrom® VIII:Ag . . . . . . . . . . . . . . . . . . . . 33 . Asserachrom® VWF:Ag . . . . . . . . . . . . . . . . . . . 16 Asserachrom® X:Ag . . . . . . . . . . . . . . . . . . . . . 31 Asserachrom® β-TG . . . . . . . . . . . . . . . . . . . . . 16 Asserachrom® HPIA (ELISA) . . . . . .. . . . . . . . . . 12 Asserachrom® IX:Ag . . . . . . . . . . . . . . . . . . . . . 11 Asserachrom® PF4 . . . . . . . . . . . . . . . . . . . . . . . 16 Calibrated Automated Thrombogram®. . . . . . . 26 CBS 31.39 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 CBS 34.47 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 CD146, clone COM2F6, purified. . . . . . . . . . . . 30 CD146, clone COM3D9, purified. . . . . . . . . . . 30 CD146, clone COM5G6, purified. . . . . . . . . . . . 30 CD146, clone COM7A4, Biotin . . . . . . . . . . . . . 30 CD146, clone COM7A4, FITC . . . . . . . . . . . . . . 30 CD146, clone COM7A4, purified. . . . . . . . . . . . 30 CD146, clone S-Endo 1, Biotin . . . . . . . . . . . . . 30 . CD146, clone S-Endo 1, FITC . . . . . . . . . . . . . . 30 CD146, clone S-Endo 1, PE . . . . . . . . . . . . . . . . 30 CD146, clone S-Endo 1, purified. . . . . . . . . . . . 30 CD32, clone 2B2, purified . . . . . . . . . . . . . . . . 31 CD36, clone 10.5, FITC . . . . . . . . . . . . . . . . . . 30 CD36, clone 10.5, PE . . . . . . . . . . . . . . . . . . . . 31 CD36, clone 10.5, purified . . . . . . . . . . . . . . . . 30 CD41, clone PL2-49, FITC . . . . . . . . . . . . . . . . . 30 CD41, clone PL2-49, PE . . . . . . . . . . . . . . . . . . 30 CD41, clone PL2-49, purified . . . . . . . . . . . . . . 30 CD42b, clone ALMA 19, FITC . . . . . . . . . . . . . . 30 CD42b, clone ALMA 19, PE . . . . . . . . . . . . . . . . 30 CD42b, clone ALMA 19, purified . . . . . . . . . . . 30 CD61, clone 4F8, FITC . . . . . . . . . . . . . . . . . . . 30 CD61, clone LYP18, FITC . . . . . . . . . . . . . . . . . 31 CD61, clone LYP18, PE . . . . . . . . . . . . . . . . . . . 31 CD61, clone LYP18, purified . . . . . . . . . . . . . . 31 39 Item Page(s) CD61, clone4f8, purifed . . . . . . . . . . . . . . . . . 30 CD62P, clone LYP20, FITC . . . . . . . . . . . . . . . 30 CD62P, clone LYP20, PE . . . . . . . . . . . . . . . . . 30 CD62P, clone LYP20, purified . . . . . . . . . . . . . 30 Cellquant calibrator . . . . . . . . . . . . . . . . . . . . 29 Cellquant PNH . . . . . . . . . . . . . . . . . . . . . . . . 29 Ctl. Neg. lgG1 - FITC (2DNP2H11) . . . . . . . . . . 30 Ctl. Neg. lgG1 - PE (2DNP2H11) . . . . . . . . . . . 30 Ctl. Neg. lgG1 - purified (2DNP2H11) . . . . . . . 30 Ctl. Neg. lgG2a PE (2DNP16C12) . . . . . . . . . . 31 Ctl. Neg. lgG2a purified (2DNP16C12) . . . . . . 31 Ctl. Neg. lgG2a - FITC (2DNP16C12) . . . . . . . . 31 Ctl. Neg. lgG2b - FITC (2DNP14G5) . . . . . . . . . 31 Ctl. Neg. lgG2b PE (2DNP14G5) . . . . . . . . . . . . 31 Ctl. Neg. lgG2b purified (2DNP14G5) . . . . . . . 31 D-Di Test®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Dispensing Tip Assembly . . . . . . . . . . . . . . . . 27 Dispensing Tip/Ascent . . . . . . . . . . . . . . . . . . 27 Ecarin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 External Quality Assessment Program . . . . . . 19 F.S. Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 F.S. Test Unit . . . . . . . . . . . . . . . . . . . . . . . . . . 15 FDP Plasma . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 FDP Plasma Latex . . . . . . . . . . . . . . . . . . . . . . 15 Fibrinogen, clone 9F9, FITC . . . . . . . . . . . . . . 30 FluCa Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 FS/FDP Plasma Test Cards . . . . . . . . . . . . . . . . 15 Halogen Lamp . . . . . . . . . . . . . . . . . . . . . . . . . 27 HPA1 kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Immulon Round Bottom plate, 2HB . . . . . . . 27 Liatest® AT III . . . . . . . . . . . . . . . . . . . . . . . . . 12 Liatest® C4b-BP. . . . . . . . . . . . . . . . . . . . . . . . 34 Liatest® Protein S . . . . . . . . . . . . . . . . . . . . . . 12 Megamix. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Miscellaneous Parts . . . . . . . . . . . . . . . . . . . . 8 MP Reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 PAlg kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Platelet Calibrator . . . . . . . . . . . . . . . . . . . . . . 29 Platelet GP Receptors . . . . . . . . . . . . . . . . . . . 29 Platelet Gp Screen . . . . . . . . . . . . . . . . . . . . . . 29 Platelet gpllb/llla Occupancy . . . . . . . . . . . . . . 29 Platelet VASP/P2Y12 . . . . . . . . . . . . . . . . . . . . 29 Polyethylene Glycol . . . . . . . . . . . . . . . . . . . . . 18 PPP Reagent . . . . . . . . . . . . . . . . . . . . . . . . . . 26 PPP Reagent High . . . . . . . . . . . . . . . . . . . . . . 26 PPP Reagent Low . . . . . . . . . . . . . . . . . . . . . . 26 PRP Reagent . . . . . . . . . . . . . . . . . . . . . . . . . . 26 PTT-LA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Purified β2-GP1 . . . . . . . . . . . . . . . . . . . . . . . . 35 Purified APC . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Purified AT III . . . . . . . . . . . . . . . . . . . . . . . . . 35 Purified Factor X . . . . . . . . . . . . . . . . . . . . . . . 35 Purified Factor Xa . . . . . . . . . . . . . . . . . . . . . . 35 Main Index (continued) Item Page(s) Purified Fibrinogen . . . . . . . . . . . . . . . . . . . . . 35 Purified Heparin Cofactor II . . . . . . . . . . . . . . 35 Purified Thrombin . . . . . . . . . . . . . . . . . . . . . . 35 Purified VWF . . . . . . . . . . . . . . . . . . . . . . . . . . 35 r-Hirudin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Redquant PNH . . . . . . . . . . . . . . . . . . . . . . . . . 29 STA® C.K. Prest 5 . . . . . . . . . . . . . . . . . . . . . . . 10 STA® CaCl2 . . . . . . . . . . . . . . . . . . . . . . . . . . 18 . STA® Calibrator HBPM/LMWH . . . . . . . . . . . . . .17 STA® Cleaner Solution . . . . . . . . . . . . . . . . . . . 18 STA® Coag Control N + ABN . . . . . . . . . . . . . . 17 STA Compact Max® Coagulation System . . . . . . 4 STA Compact Max® Coagulation System . . . . . . 4 with Cap Piercing 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® Hepanorm H. . . . . . . . . . . . . . . . . . . . . . . 17 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® Neoplastine® CI 10 . . . . . . . . . . . . . . . . . 10 STA® Neoplastine® CI 5 . . . . . . . . . . . . . . . . . . 10 STA® Neoplastine® CI Plus 10 . . . . . . . . . . . . . 10 STA® Neoplastine® CI Plus . . . . . . . . . . . . . . . . 10 STA® Owren-Koller Buffer . . . . . . . . . . . . . . . . 18 STA® Procoag - PPL . . . . . . . . . . . . . . . . . . . . . 33 STA® PTT Automate 5 . . . . . . . . . . . . . . . . . . . 10 STA® Quality HBPM/LMWH . . . . . . . . . . . . . . . 17 STA® Reptilase . . . . . . . . . . . . . . . . . . . . . . . . 10 STA® Rotachrom® Heparin 4 . . . . . . . . . . . . . . 12 STA® Rotachrom®Heparin 8 . . . . . . . . . . . . . . . 12 STA® Satellite® Hemostasis System . . . . . . . . . 5 STA® Stachrom® Antiplasmin . . . . . . . . . . . . . . 16 Item Page(s) STA® Stachrom® AT III . . . . . . . . . . . . . . . . . . 13 STA® Stachrom® Plasminogen . . . . . . . . . . . . 16 STA® Stachrom® Protein C . . . . . . . . . . . . . . . 13 STA® Stachrom® TAFI . . . . . . . . . . . . . . . . . . . 33 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 . . . . . . . . . . . . . . . . . . . . . 17 STA® VWF:Ag Calibrator . . . . . . . . . . . . . . . . . 17 STA-R Evolution® Expert Series . . . . . . . . . . . 3 Hemostasis System STA-R Evolution® Expert Series Hemostasis . . 3 System with Cap Piercing STA-R Evolution®, STA Compact Max® and STA 7-8 Satellite® Disposables and Accessories Stachrom® Heparin . . . . . . . . . . . . . . . . . . . . . 12 Stachrom® Heparin Cofactor II . . . . . . . . . . . . 34 Stachrom® PAI . . . . . . . . . . . . . . . . . . . . . . . . . 34 Staclot ® LA . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Staclot ® VIIa-rTF . . . . . . . . . . . . . . . . . . . . . . 33 STart Disposables and Accessories . . . . . . . . . 8 STart Hemostasis Analyzer. . . . . . . . . . . . . . . . 6 Thrombin Calibrator . . . . . . . . . . . . . . . . . . . . 26 40 DIAGNOSTICA STAGO, Inc. Five Century Drive . Parsippany, N J 07054 800.222.COAG 973.631.1200 973.631.1618 (fax) www.stago-us.com