classification Test, Qualitative And Quantitative Factor Deficiency Manufacturer:

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gudid vW Select Kit (Ristocetin Cofactor) Manufacturer: Bio/Data Corporation

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gudid vW Normal Control Plasma Manufacturer: Bio/Data Corporation

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gudid vW Factor Assay (Ristocetin Cofactor) Manufacturer: Bio/Data Corporation

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gudid Lyophilized Platelets Manufacturer: Bio/Data Corporation

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gudid vW Abnormal Control Plasma Manufacturer: Bio/Data Corporation

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gudid vW Normal Reference Plasma Manufacturer: Bio/Data Corporation

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gudid Lyophilized Platelets Manufacturer: Bio/Data Corporation

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gudid HemosIL Protein S Activity Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid Coatest SP FVIII Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid Coatest SP4 FVIII Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Protein C Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid ELECTRACHROME Factor VIII Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid Coamatic Factor VIII Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid Coamatic Protein C Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Plasminogen Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL von Willebrand Factor Activity Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Free Protein S Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL ProClot Diluent 100 mL Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL von Willebrand Factor Antigen Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Plasmin Inhibitor Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL ProClot Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid For the quantitative determination of free protein S antigen in human plasma collected from venous blood samplesin 3.2 % sodium citrate tubes on the BCS XP System, the SYSMEX CS-2500 analyzer and the SYSMEX CS-5100 analyzer. Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Quantative determination of a2-antiplasmin activity as an aid in the diagnosis of inherited or acquired deficiencies and in management of fibrinolytic therapy Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Coagulation test for the quantitative determination of protein C activity in human plasma Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Determination of the functional activity of protein S in human plasma Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid For the quantitative determination of von Willebrand factor (vWF) antigen concentration in human sodium citrated plasma Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Determination of Factor VIII (antihemophilic factor) activity in human plasma Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid HemosIL Chromogenic Factor IX Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid vW Reference Plasma Normal Manufacturer: CHRONO-LOG CORP

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gudid Ristocetin Cofactor Assay Kit Manufacturer: CHRONO-LOG CORP

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gudid Tris Buffered Saline Manufacturer: CHRONO-LOG CORP

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gudid Lyophilized Human Platelets 6mL, TBS 12mL Manufacturer: CHRONO-LOG CORP

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gudid vW Reference Plasma Deficient Manufacturer: CHRONO-LOG CORP

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gudid Ristocetin 7.5 mg/Vial Manufacturer: CHRONO-LOG CORP

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gudid Asserachrom tPA Manufacturer: DIAGNOSTICA STAGO

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gudid Asserachrom Free Protein S Manufacturer: DIAGNOSTICA STAGO

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gudid Asserachrom Total Protein S Manufacturer: DIAGNOSTICA STAGO

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gudid Asserachrom IX:Ag Manufacturer: DIAGNOSTICA STAGO

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gudid Asserachrom VWF:Ag Manufacturer: DIAGNOSTICA STAGO

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gudid STA - Staclot Protein C 1 Manufacturer: DIAGNOSTICA STAGO

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gudid STA - Staclot Protein S Manufacturer: DIAGNOSTICA STAGO

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gudid STA - Staclot Protein C 3 Manufacturer: DIAGNOSTICA STAGO

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gudid STA - Stachrom Protein C Manufacturer: DIAGNOSTICA STAGO

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gudid STA - Stachrom Antiplasmin Manufacturer: DIAGNOSTICA STAGO

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gudid Liatest Protein S Manufacturer: DIAGNOSTICA STAGO

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gudid STA - Liatest Free Protein S 6 Manufacturer: DIAGNOSTICA STAGO

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gudid Coagulation test for the quantitative determination of protein C activity in human plasma Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Determination of the functional activity of protein S in human plasma Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid For the quantitative determination of von Willebrand factor (vWF) antigen concentration in human sodium citrated plasma Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Determination of Factor VIII (antihemophilic factor) activity in human plasma Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid For the quantitative determination of free protein S antigen in human plasma collected from venous blood samplesin 3.2 % sodium citrate tubes on the BCS XP System, the SYSMEX CS-2500 analyzer and the SYSMEX CS-5100 analyzer. Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Quantative determination of a2-antiplasmin activity as an aid in the diagnosis of inherited or acquired deficiencies and in management of fibrinolytic therapy Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Ristocetin Cofactor Abnormal Control Plasma Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Helena Ristocetin - 10 mg/mL Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Lyophilized Platelets Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Ristocetin Cofactor Assay Kit Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Tris-Buffered Saline Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Free Protein S Reagent Manufacturer: HELENA LABORATORIES CORPORATION

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gudid von Willebrand Factor Antigen Rocket Kit Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Rocket Stain Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Protein S Antigen Rocket Kit Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Tris-Tricine Buffer Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Protein C Antigen Rocket Kit Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Lyophilized Platelets Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Monoclonal Free Protein S ELISA Kit Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Protein S ELISA Kit Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Protein C ELISA Kit Manufacturer: HELENA LABORATORIES CORPORATION

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gudid von Willebrand Factor Antigen ELISA Kit (96 tests) Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Factor XII Deficient Substrate Plasma Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Factor XI Deficient Substrate Plasma Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Factor X Deficient Substrate Plasma Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Factor IX Deficient Substrate Plasma Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Factor VIII Deficient Substrate Plasma Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Factor VII Deficient Substrate Plasma Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Factor V Deficient Substrate Plasma Manufacturer: HELENA LABORATORIES CORPORATION

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gudid Factor II Deficient Substrate Plasma Manufacturer: HELENA LABORATORIES CORPORATION

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gudid 96 Test enzyme immunoassay kit for the determination of FIX Antigen Manufacturer: Affinity Biologicals Inc

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gudid 96 Test enzyme immunoassay kit for the determination of FVIII Antigen Manufacturer: Affinity Biologicals Inc

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gudid For Use with Factor VIII Antibody Screen Manufacturer: IMMUCOR GTI DIAGNOSTICS, INC.

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gudid For Use with Factor VIII Antibody Screen Manufacturer: IMMUCOR GTI DIAGNOSTICS, INC.

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gudid For Use with Factor VIII Antibody Screen Manufacturer: IMMUCOR GTI DIAGNOSTICS, INC.

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gudid The Factor VIII Antibody Screen is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect reactive with recombinant human factor VIII (FVIII) in human serum and plasma. Manufacturer: IMMUCOR GTI DIAGNOSTICS, INC.

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gudid Human Protein C NL NANORIDTM Radial Immunodiffusion Kit Manufacturer: THE BINDING SITE GROUP LIMITED

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gudid EIA-VON WILLEBR. Manufacturer: Ramco Laboratories, Inc.

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gudid STA - Deficient VIII Manufacturer: DIAGNOSTICA STAGO

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gudid Protein S Kit 80-160 DET Manufacturer: R 2 DIAGNOSTICS, INC.

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gudid INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Von Willebrand Factor Activity (VWF:Act) in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY OF THE TEST Von Willebrand Factor Antigen (VWF:Ag or Factor VIII-related protein) is a plasma protein found in circulation combined by non-covalent interactions with Factor VIII (FVIII:C), a pro-coagulant protein also known as the anti-hemophilic factor. Deficiency of FVIII causes classic hemophilia while deficiency of VWF causes von Willebrand disease. Von Willebrand Disease is characterized by a deficiency or defect of VWF. Greater than 70% of Von Willebrand disease patients have a type 1 deficiency while approximately 20% have a type II deficiency. The laboratory diagnosis of Von Willebrand disease may require both quantitative and qualitative (functional) determinations to differentiate the two predominant subtypes of the disease, type I and type II. The classification of Von Willebrand disease into subtypes is important in determining the course of clinical treatment. PRINCIPLE OF THE TEST The REAADS VWF:Act assay is a sandwich ELISA. A monoclonal capture antibody specific for the portion of VWF which binds platelets is coated to 96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells. The plates are washed to remove unbound proteins and other plasma molecules. Bound antigen is quantitated using horseradish peroxidase (HRP) conjugated anti-human VWF detection antibody. Following incubation, unbound conjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in O.D. units with a spectrophotometer at 450 nm. Patient VWF:Act in relative percent concentration is determined against a curve made from the reference plasma provided with the kit. Refer to Product Package Insert. Manufacturer: CORGENIX MEDICAL CORPORATION

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gudid INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Von WillebrandFactor Antigen (VWF: Ag) in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY THE TESTVon Willebrand Factor Antigen (VWF:Ag or Factor VIII-related protein) is a plasma protein found incirculation combined by non-covalent interactions with Factor VIII (FVIII:C), a pro-coagulant protein alsoknown as the anti-hemophilic factor. These two proteins show distinct biochemical and functionalproperties as well as different antigenic determinants; their plasma levels may vary independently ofeach other. Deficiency of FVIII causes classic hemophilia while deficiency of VWF causes VonWillebrand disease. VWF:Ag plays a very important role in hemostasis. The prevalence of Von Willebrand disease has been estimated to be 1-3% of thegeneral population. Approximately 80% of Von Willebrand disease patients have a type I deficiency.The laboratory diagnosis of Von Willebrand disease may require both quantitative and qualitative(functional) determinations.PRINCIPLE OF THE TESTREAADS VWF:Ag assay is a sandwich ELISA. A capture antibody specific for human VWF is coated to96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells, allowing any availableVWF:Ag to bind to the anti-human VWF antibody on the microwell surface. The plates are washed toremove unbound proteins and other plasma molecules. Bound VWF:Ag is quantitated using horseradishperoxidase (HRP) conjugated anti-human VWF detection antibody. Following incubation, unboundconjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogenperoxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in opticaldensity (O.D.) units with a spectrophotometer at 450nm. Patient VWF:Ag in relative percentconcentration is determined against a curve made from the reference plasma provided with the kit. Refer to product package insert. Manufacturer: CORGENIX MEDICAL CORPORATION

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gudid INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Protein C Antigen in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE TESTProtein C deficiency, either congenital or acquired, may lead to serious thrombotic events such as thrombophlebitis, deep vein thrombosis, or pulmonary embolism. Patients with a congenital heterozygous deficiency may present with venous thrombosis in young adulthood, while patients with the rare homozygous deficiency present with massive thrombosis (purpura fulminans) during the neonatal period. The prevalence of Protein C deficiency in the general population has been estimated at 1 in 300. In younger patients (<40-45 years) with recurrent venous thrombosis, the frequency of Protein C deficiencies may be as high as 10 to 15%. A decreased Protein C activity in plasma may be the result of low concentrations and function (type I) or only low function (type II).PRINCIPLE OF THE TESTThe Protein C Antigen assay is a sandwich ELISA. A capture antibody specific for human Protein C is coated to 96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells, allowing any available Protein C to bind to the anti-human Protein C antibody on the microwell surface. The plates are washed to remove unbound proteins and other plasma molecules. Bound Protein C is quantitated using horseradish peroxidase (HRP) conjugated anti-human Protein C detection antibody. Following incubation, unbound conjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in optical density (O.D.) units with a spectrophotometer at 450nm. Protein C Antigen relative percent concentrations in patient plasma are determined against a curve prepared from the reference plasma provided with the kit.Refer to Product Package Insert. Manufacturer: CORGENIX MEDICAL CORPORATION

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gudid INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Free Protein S Antigen in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE PROTEIN S TESTProtein S is a vitamin K-dependent protein synthesized in the liver, vascular endothelium, and megakaryocytes, which plays an important physiologic role in the Protein C Anticoagulant System. This anticoagulant system is one of the major regulators of hemostasis by inhibiting clot formation and by promoting fibrinolysis. Protein S functions as a cofactor for activated Protein C on the vascular membrane to facilitate the degradation of clotting factors Va and VIIIa, down-regulating clot formation. In normal plasma approximately 40% of Protein S circulates as a free molecule, while 60% is complexed with C4b, a plasma protein of the classical complement pathway. Only Free Protein S is functionally active and able to bind to activated Protein C, while the complexed form of Protein S is not.Protein S deficiency, either congenital or acquired, may lead to serious thrombotic events such as thrombophlebitis, deep vein thrombosis, or pulmonary embolism. The prevalence of Protein S deficiency has been estimated to be less than 1 case per 300 in the general population. Two-thirds of patients with a congenital deficiency of Protein S (levels less than 50% of normal) may present with venous thrombosis in young adulthood. In young patients (<35 years) with a history of thrombosis, the prevalence may be as high as 15 to 18%. Acquired Protein S deficiency may be seen during pregnancy, oral contraceptive or oral anticoagulant therapy, liver disease, diabetes mellitus, postoperative complications, septicemia, and various inflammatory syndromes. A decreased Protein S activity in plasma may be the result of low concentrations or abnormal function of the Protein S molecule.Refer to Product Package Insert. Manufacturer: CORGENIX MEDICAL CORPORATION

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gudid INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Total and Free Protein S Antigen in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE PROTEIN S TESTProtein S is a vitamin K-dependent protein synthesized in the liver, vascular endothelium, and megakaryocytes, which plays an important physiologic role in the Protein C Anticoagulant System. This anticoagulant system is one of the major regulators of hemostasis by inhibiting clot formation and by promoting fibrinolysis. Protein S functions as a cofactor for activated Protein C on the vascular membrane to facilitate the degradation of clotting factors Va and VIIIa, downregulating clot formation. In normal plasma approximately 40% of Protein S circulates as a free molecule, while 60% is complexed with C4b, a plasma protein of the classical complement pathway. Only Free Protein S is functionally active and able to bind to activated Protein C, while the complexed form of Protein S is not.Protein S deficiency, either congenital or acquired, may lead to serious thrombotic events such as thrombophlebitis, deep vein thrombosis, or pulmonary embolism. The prevalence of Protein S deficiency has been estimated to be less than 1 case per 300 in the general population. Two-thirds of patients with a congenital deficiency of Protein S (levels less than 50% of normal) may present with venous thrombosis in young adulthood. In young patients (<35 years) with a history of thrombosis, the prevalence may be as high as 15 to 18%.7 Acquired Protein S deficiency may be seen during pregnancy, oral contraceptive or oral anticoagulant therapy, liver disease, diabetes mellitus, postoperative complications, septicemia and various inflammatory syndromes.8 A decreased Protein S activity in plasma may be the result of low concentrations or abnormal function of the Protein S molecule.Refer to Product Package Insert. Manufacturer: CORGENIX MEDICAL CORPORATION

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gudid ACTICLOT C KIT Manufacturer: Biomedica ADI Inc.

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gudid ACTICLOT PROTEIN S Manufacturer: Biomedica ADI Inc.

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FDA Product Code: GGP