classification System, Multipurpose For In Vitro Coagulation Studies Manufacturer:

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gudid PAP-8E Software CD Manufacturer: Bio/Data Corporation

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gudid Lupus Anticoagulant Confirmation Reagent Manufacturer: Bio/Data Corporation

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gudid Sodium Citrate Manufacturer: Bio/Data Corporation

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gudid Tris Buffered Saline Manufacturer: Bio/Data Corporation

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gudid HemosIL CL Probe Conditioner Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid ACL TOP 970 CL Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL CL Rinse solution Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL CL Triggers Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid ACL ELITE (Refurbished) Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid BIO-FLASH Manufacturer: BIOKIT, S.A.

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gudid HemosIL AcuStar Cleaning Solution Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Chromogenic Optic test 160umol L Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Rinse Solution 2L (ACLFutura Advance) Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Rinse Solution 4L (ACL TOP Family) Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid ACL AcuStar Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL AcuStar Triggers Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL AcuStar System Rinse Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid ACL ELITE PRO (Refurbished) Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Special Test Control Level 1 Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid ACL ELITE Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid COAGULOMETRIC OPTIC TEST, ACL FUTURA Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Chromogenic Optic Test Kit Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid KIT,CHROM OPTIC TEST 160MMOL L,FUTU ADVA Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Coagulation Optic Test Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid ACL ELITE PRO Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Special Test Control Level 2 Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid GEM Test ACT-LR Cartridges Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid GEM Test ACT+ Cartridges Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid GEM Test APTT Cartridges Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid GEM Test Citrate PT Cartridges Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid GEM Test PT Cartridges Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid Electronic Verification Cartridge Kit Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid Temperature Verification Cartridges Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Wash-R Emulsion 1000 mL Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Rinse Solution (ACL TOP Family) 4000 mL Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid Critical Care/HemosIL Cleaning Agent (Clean B) Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid Rotors 100 pcs 2000 wells Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Rinse Solution (ACL Futura Advance) 2 LIT Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid 7.2 Volt 2.5Ah NiMH Manufacturer: R & D Batteries, Inc.

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gudid 12 Volt 3.0Ah NiCd - Retrofit Manufacturer: R & D Batteries, Inc.

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gudid 8.4 Volt .800Ah NiCd - Retrofit Manufacturer: R & D Batteries, Inc.

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gudid 12 Volt 5.0 Ah NiCd Manufacturer: R & D Batteries, Inc.

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gudid 7.2 Volt .70Ah NiCd Manufacturer: R & D Batteries, Inc.

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gudid 14.4 Volt .70Ah NiCd Manufacturer: R & D Batteries, Inc.

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gudid 7.2 Volt 1.8Ah NiCd Manufacturer: R & D Batteries, Inc.

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gudid 7.2 Volt 5.0Ah NiCd Manufacturer: R & D Batteries, Inc.

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gudid Standard Human Plasma for the calibration of coagulation and fibrinolysis tests Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid The BFT II Analyzer is a semi-automated device intended for use to determine diagnostic parameters Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Washing Solution is used for cleaning the Siemens Healthcare Diagnostics coagulation analyzers Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Supplementary Reagent for coagulation tests Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid The cuvettes serve coagulation tests as a reaction vessel. Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid The cuvettes serve coagulation tests as a reaction vessel. Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid For calibration of the Berichrom Heparin assay for measurement of unfractionated heparin Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid For calibration of the Berichrom Heparin assay for measurement of low molecular weight heparin Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid CONTROL TEST 550-90 PROFICIENCY 5L Manufacturer: MEDTRONIC, INC.

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gudid The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. Manufacturer: Tem Innovations GmbH

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gudid The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. Manufacturer: Tem Innovations GmbH

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gudid The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. Manufacturer: Tem Innovations GmbH

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gudid The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. Manufacturer: Tem Innovations GmbH

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gudid The EXTEM assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). CFT and alpha (Speed of Clot Formation) are complementary parameters and should be used in conjunction with the main parameters Clotting Time (CT) and Clot Firmness (A20/MCF). Manufacturer: Tem Innovations GmbH

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gudid ROTROL N is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM delta Thromboelastometry System. For in vitro diagnostic use only. Manufacturer: Tem Innovations GmbH

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gudid The ROTEM delta is designed for in-vitro diagnostic use by professionals in a laboratory environ-ment. The ROTEM delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.The hep-tem assay is a semi-quantitative in vitro diagnostic assay used to inactivate heparin in patients receiving unfractionated heparin on the ROTEM delta. To monitor the coagulation process citrated whole blood specimens are used. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). Manufacturer: Tem Innovations GmbH

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gudid The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM delta Thromboelastometry System to monitor the clot firmness of citrated whole blood specimens after blocking platelet contribution to the clot firmness. fib-tem is always used in conjunction with ex-tem. Clotting characteristics are described by the functional parameter Clot Firmness (A20/MCF). Manufacturer: Tem Innovations GmbH

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gudid The APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM delta Thromboelastometry System to monitor the clot firmness of citrated whole blood specimens after blocking hyperfibrinolysis by aprotinin. ap-tem is always used in conjunction with ex-tem. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). CFT and alpha (Speed of Clot Formation) are complementary parameters and should be used in conjunction with the main parameters Clotting Time (CT) and Clot Firmness (A20/MCF). Manufacturer: Tem Innovations GmbH

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gudid The ROTEM delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively. Manufacturer: Tem Innovations GmbH

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gudid Destiny System Fluid Manufacturer: TCOAG IRELAND LIMITED

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gudid TriniCAL Reference Plasma Manufacturer: TCOAG IRELAND LIMITED

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gudid STA R Max (with cap piercing option) Manufacturer: DIAGNOSTICA STAGO

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gudid STA R Max Manufacturer: DIAGNOSTICA STAGO

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gudid STA R Max Manufacturer: DIAGNOSTICA STAGO

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gudid STA R Max (with cap piercing option) Manufacturer: DIAGNOSTICA STAGO

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gudid STA Compact Max Manufacturer: DIAGNOSTICA STAGO

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gudid STA Compact Max (with cap piercing option) Manufacturer: DIAGNOSTICA STAGO

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gudid STA-R Evolution Expert Series (with cap piercing option) Manufacturer: DIAGNOSTICA STAGO

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gudid STA-R Evolution Expert Series Manufacturer: DIAGNOSTICA STAGO

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gudid STA Satellite Manufacturer: DIAGNOSTICA STAGO

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gudid Supplementary Reagent for coagulation tests Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Standard Human Plasma for the calibration of coagulation and fibrinolysis tests Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Hemotec Whole Blood Control Kit Large Manufacturer: ANALYTICAL CONTROL SYSTEMS INC

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gudid Whole Blood Control Level III Manufacturer: ANALYTICAL CONTROL SYSTEMS INC

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gudid Whole Blood Control Level II Manufacturer: ANALYTICAL CONTROL SYSTEMS INC

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gudid Whole Blood Control Level I Manufacturer: ANALYTICAL CONTROL SYSTEMS INC

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gudid .02M Calcium Chloride Manufacturer: ANALYTICAL CONTROL SYSTEMS INC

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gudid Actalyke QC Kit - AQC-LP Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Actalyke QC Kit - AQC-HP Manufacturer: HELENA LABORATORIES CORPORATION

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gudid AggRAM Module (Domestic) Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Owren's Veronal Buffer Manufacturer: HELENA LABORATORIES CORPORATION

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gudid NORM-TROL 1 Coagulation Control Manufacturer: HELENA LABORATORIES CORPORATION

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gudid AggRAM Module (110/220 V) Manufacturer: HELENA LABORATORIES CORPORATION

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gudid AggRAM Analyzer, Windows 7 (110V/220V) Manufacturer: HELENA LABORATORIES CORPORATION

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gudid AggRAM Analyzer (110V/220V) Manufacturer: HELENA LABORATORIES CORPORATION

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gudid AggRAM Analyzer, Windows 2000 (110V/220V) Manufacturer: HELENA LABORATORIES CORPORATION

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gudid CARTRIDGE 402-02 ACT RACT 13 LAN Manufacturer: MEDTRONIC, INC.

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gudid CONTROL 550-01 CLOTTRAC CWB 11L 15BX Manufacturer: MEDTRONIC, INC.

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gudid LINEARITY KIT 313-50 HEPLINE Manufacturer: MEDTRONIC, INC.

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gudid A fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use Manufacturer: SYSMEX CORPORATION

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gudid A fully automated blood coagulation analyzer intended for in vitro diagnostic use. Manufacturer: SYSMEX CORPORATION

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gudid A fully automated blood coagulation analyzer intended for in vitro diagnostic use. Manufacturer: SYSMEX CORPORATION

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gudid The CN-Series (CN-6000) is a fully automated coagulation analyzer intended for in vitro diagnostic use in the clinical laboratory. The instrument analyzes citrated plasma samples (3.2 % sodium citrate) collected from venous blood, using clotting, chromogenic and immunoassay methods. The performance of this device has not been established in neonate and pediatric patient populations. Manufacturer: SYSMEX CORPORATION

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FDA Product Code: JPA