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510(k) Data Aggregation

    K Number
    K060968
    Device Name
    STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW
    Manufacturer
    WORTHAM LABORATORIES INC
    Date Cleared
    2007-05-15

    (403 days)

    Product Code
    GIZ, GFO, GGC, GGN, GIL, GJS, KQJ
    Regulation Number
    864.5425
    Why did this record match?
    Product Code :

    GIZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wortham Laboratories Stasis 1 Coagulation Control (Normal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT, and Fibrinogen values in the normal range. Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the moderate abnormal range. Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the strongly abnormal range. Wortham Laboratories Serathan-B PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-B is a moderately sensitive thromboplastin reagent. Wortham Laboratories Serathan-A PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-A is a highly sensitive thromboplastin reagent. Wortham Laboratories Intrin-EA APTT is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-EA reagent is sensitive to mild coagulopathies. Wortham Laboratories Intrin-SI is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-SI reagent is sensitive to heparin and lupus anticoagulant plasmas. Wortham Laboratories Fibrinogen Control Low, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays. Wortham Laboratories Fibrinogen Control Normal, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays. Wortham Laboratories Thrombin Reagent is intended for thrombin to convert fibrinogen in the quantitative determination of fibrinogen in plasma samples. Wortham Laboratories Fibrinogen Assay Set, containing a complete set of Normal Fibrinogen Control (200-400 mg/dl), Thrombin Reagent (100 IU/ml), and Fibrinogen Buffer, is intend for use in the quantitative determination of fibrinogen in plasma samples. Wortham Laboratories Heparin Control Level 1, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring. Wortham Laboratories Heparin Control Level 2, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring. Wortham Laboratories Calcium Chloride Solution 0.02 M (CaCl2) is intended for quantitative use with ellagic acid (Intrin-EA) or silicon particulate activators (Intrin-SI) in performing the activated partial thromboplastin time (APTT) on citrated plasma. Wortham Laboratories Fibrinogen Buffer is designed as a diluent for fibrinogen studies.
    Device Description
    Wortham Laboratories Stasis 1 Coagulation Control (Normal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBsAg and negative for antibodies to HIV and HCV. Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBSAg and negative for antibodies to HIV and HCV. Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBsAg and negative for antibodies to HIV and HCV. Wortham Laboratories Serathan-B PT Reagent is a liquid stable extract of rabbit thromboplastin containing calcium, stabilizer and buffer. Serathan-B is an in-vitro diagnostic reagent intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays for Factors II, V. VII and X. Wortham Laboratories Scrathan-A PT Reagent is a liquid stable extract of rabbit thromboplastin containing calcium, stabilizer and buffer. Serathan-A is an in-vitro diagnostic reagent intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays for Factors II, V. VII and X. Wortham Laboratories Intrin-EA APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic hemostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit cephalin with the surface activator ellagic acid. Wortham Laboratories Intrin-SI APTT Reagent is a liquid stable extract of rabbit brain thromboplastin, containing stabilizers and buffers. Intrin-SI is an in-vitro diagnostic reagent intended for use for the performance of a citrated Partial Thromboplastin Time (APTT) testing and quantitative PTT-based factor assays for Factors XII, XI, IX and VIII. Wortham Laboratories Fibrinogen Low Control is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV. Wortham Laboratories Fibrinogen Normal Control is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV. Wortham Laboratories Thrombin Reagent is a liquid stable preparation of activated bovine proteins (Factor IIa). Wortham Laboratories Fibrinogen Assay Set contains a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers, buffers, and a bovine reagent and buffer solution which are also provided in the set. Each unit of source material used in the preparation of the control has been tested by an EDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV. Wortham Laboratories Heparin Control Level 1 is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV. Wortham Laboratories Heparin Control Level 2 is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodics to HIV and HCV. Wortham Laboratories Calcium Chloride Solution 0.02 M (CaCl2) is intended for quantitative use with ellagic acid (Intrin-EA) or silicon particulate activators (Intrin-SI) in performing the activated partial thromboplastin time (APTT) on citrated plasma. Fibrinogen Buffer : 1.3% TAPSO Buffer. 0.9% sodium chloride, 0.1% sodium azide and stabilizers; pH 7.35 ± 0.05.
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    K Number
    K042941
    Device Name
    DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2004-12-02

    (38 days)

    Product Code
    GIZ
    Regulation Number
    864.5425
    Why did this record match?
    Product Code :

    GIZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dade Behring Heparin Calibrator is an in vitro diagnostic product used to calibrate the Berichrom® Heparin assay for the measurement of unfractionated heparin. Dade Behring Heparin Controls are in vitro diagnostic products intended to be used as assayed, unfractionated heparin quality control materials for the Berichrom® Heparin assay.
    Device Description
    Dade Behring Heparin Calibrator and Controls are lyophilized products prepared from citrated human plasma and contain unfractionated heparin from a porcine source. The kit consists of a calibrator and two levels of assayed controls intended to monitor the performance of Berichrom® Heparin reagent when testing for unfractionated heparin using coagulation analyzers.
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    K Number
    K023309
    Device Name
    CONTROL PLASMA N
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2002-11-01

    (29 days)

    Product Code
    GIZ
    Regulation Number
    864.5425
    Why did this record match?
    Product Code :

    GIZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Control Plasma N is assayed for use as an accuracy control of the following parameters in the normal range: Prothrombin time (PT); Activated partial thromboplastin time (aPTT); Thrombin time (TT)*; Batroxobin time*; Fibrinogen; Coagulation factors II, V, VII, VIII, VWfF IX, X, XI, XII and XIII **; Inhibitors: Antithrombin III, Protein C, Protein S, as -antiplasmin, C, inhibitor**: Plasminogen; Total complement activity**, Lupus anticoagulants. (* Not for BFT ™II analyzer, ** Not available in the U.S.)
    Device Description
    Control Plasma N is a Iyophilized control prepared from pooled human plasma. stabilized with HEPES buffer solution. It is an assayed control intended to monitor and evaluate the precision and accuracy of coagulation and fibrinolysis tests in the normal range.
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    K Number
    K013708
    Device Name
    REFERENCE CHECK, CATALOG NUMBER-RCN-10
    Manufacturer
    PRECISION BIOLOGIC
    Date Cleared
    2001-12-10

    (32 days)

    Product Code
    GIZ
    Regulation Number
    864.5425
    Why did this record match?
    Product Code :

    GIZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reference Check is recommended for use in controlling the accuracy of quantitative hemostasis assays Reference Check is recommended for use in controlling the following parameters in the normal range: - Fibrinogen . - Factor II . - Factor V . - Factor VII . - Factor VIII:C - vWF: antigen ● - vWF: Ristocetin Cofactor ● - Factor IX ● - Factor X . - Factor XI . - Factor XII . - Factor XIII ● - Prekallikrein . - Protein C: antigen ● - Protein C: activity ● - Protein S: activity . - Protein S: total . - Protein S: free . - Antithrombin: activity ● - Antithrombin: antigen . - Alpha-2-antiplasmin . - Plasminogen .
    Device Description
    Reference Check is citrated human plasma collected from 20 or more carefully screened normal donors. Plasmas are pooled, buffered using 0.01M HEPES buffer, aliquoted and rapidly frozen.
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    K Number
    K003328
    Device Name
    ACCUCLOT CONTROL I, MODEL A4089
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    2001-03-01

    (128 days)

    Product Code
    GIZ
    Regulation Number
    864.5425
    Why did this record match?
    Product Code :

    GIZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001256
    Device Name
    CONTROL PLASMA N
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2000-05-24

    (35 days)

    Product Code
    GIZ
    Regulation Number
    864.5425
    Why did this record match?
    Product Code :

    GIZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K984129
    Device Name
    COAGULATION CONTROL LEVEL 1 (NORMAL)
    Manufacturer
    PACIFIC HEMOSTASIS
    Date Cleared
    1998-12-01

    (13 days)

    Product Code
    GIZ
    Regulation Number
    864.5425
    Why did this record match?
    Product Code :

    GIZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pacific Hemostasis Coagulation Control Level 1 is intended for use as a control to monitor the performance of routine coagulation assays, i.e. Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT and Fibrinogen values in the normal range.
    Device Description
    Pacific Hemostasis Coagulation Control Level 1 (Normal) is a lyophilized preparation of citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma prior to lyophilization. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found non-reactive for HBsAG and negative for antibodies to HIV and HCV.
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    K Number
    K973274
    Device Name
    ACCUCOLOR HIGH CALIBRATOR (A3089)
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    1997-10-31

    (59 days)

    Product Code
    GIZ, JBQ
    Regulation Number
    864.5425
    Why did this record match?
    Product Code :

    GIZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sigma Diagnostics ACCUCOLOR™ High Calibrator is for use with the Sigma Diagnostics ACCUCOLOR™ Antithrombin III (AT-III) to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).
    Device Description
    This product is designed for use with Accucolor Antithrombin III Assay Kit (CRS117A). The normal range of plasma Antithrombin III (AT-III) has been reported from 79-125% in Plasma 1-234 A normal population range determined at Sigma Diagnostics (n=70) was 83-119% (mean 101.1+9.8). This product provides a reference material with an assigned value slightly above the normal range.
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    K Number
    K961814
    Device Name
    THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS
    Manufacturer
    CARDIOVASCULAR DIAGNOSTICS, INC.
    Date Cleared
    1996-08-13

    (95 days)

    Product Code
    GIZ, GGC, GGN, GJS
    Regulation Number
    864.5425
    Why did this record match?
    Product Code :

    GIZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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