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510(k) Data Aggregation

    K Number
    K222831
    Device Name
    CRYOcheck Factor VIII Deficient Plasma with VWF
    Manufacturer
    Precision BioLogic Inc.
    Date Cleared
    2023-09-13

    (359 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Why did this record match?
    Product Code :

    GJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative determination of Factor VIII activity in 3.2% citrated human plasma based on the activated partial thromboplastin time (APTT) assay. It is intended to be used in identifying factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use
    Device Description
    CRYOcheck Factor VIII Deficient Plasma with VWF is normal human citrated plasma which has been immunodepleted of factor VIII and to which an exogenous source of human von Willebrand Factor (vWF) has been added and buffered with HEPES. Factor VIII has been assayed at less than 1% of normal activity levels and vWF antigen and activity are >50%. It will be provided to users frozen in small-volume aliquots (25 vials of 1.0 mL, and 25 vials of 1.5 mL). Vials will be packaged into boxes; these will be frozen during the manufacturing process and will be shipped and stored frozen until use to preserve the integrity of the components
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    K Number
    K180486
    Device Name
    HemosIL Factor XII Deficient Plasma
    Manufacturer
    Instrumentation Laboratory Co.
    Date Cleared
    2018-03-22

    (27 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Why did this record match?
    Product Code :

    GJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemosIL Factor XII Deficient Plasma immunodepleted of factor XII and intended for the in vitro diagnostic quantitative determination of factor XII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation Systems.
    Device Description
    Factor XII activity in a patient's plasma is determined by performing a modified activated partial thromboplastin time test (APTT). Patient plasma is diluted and added to plasma deficient in factor XII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of that factor in the patient plasma, interpolated from a calibration curve.
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    K Number
    K102851
    Device Name
    NOFACT VIII
    Manufacturer
    R2 DIAGNOSTICS, INC.
    Date Cleared
    2011-12-19

    (446 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Why did this record match?
    Product Code :

    GJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NoFact VIII Deficient Plasma is a human plasma immunodepleted of Factor VIII and intended for the quantitative determination of Factor VIII activity in citrated plasma from patients suspected of FVIII deficiency. FVIII activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.
    Device Description
    NoFact VIII Deficient Plasma is a human plasma immunodepleted of Factor VIII and intended for the quantitative determination of Factor VIII activity in citrated plasma from patients suspected of FVIII deficiency. FVIII activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.
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    K Number
    K102908
    Device Name
    NOFACT IX
    Manufacturer
    R2 DIAGNOSTICS, INC.
    Date Cleared
    2011-12-19

    (444 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Why did this record match?
    Product Code :

    GJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NoFact IX Deficient Plasma is a human plasma immunodepleted of Factor IX and intended for the quantitative determination of Factor IX activity in citrated plasma from patients suspected of FIX deficiency. FIX activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.
    Device Description
    NoFact IX Deficient Plasma is a human plasma immunodepleted of Factor IX and intended for the quantitative determination of Factor IX activity in citrated plasma from patients suspected of FIX deficiency. FIX activity is based on the activated partial thromboplast time. For in vitro diagnostic use.
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    K Number
    K110237
    Device Name
    HEMOSIL FACTOR VIII DEFICIENT PLASMA
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2011-07-08

    (163 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Why did this record match?
    Product Code :

    GJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemosIL Factor VIII deficient plasma is human plasma, depleted of Factor VIII, which is intended for the in vitro diagnostic quantitative determination of Factor VIII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on the ACL TOP® Family analyzers. HemosIL Factor VIII deficient plasma is indicated for use on patients who are suspected of congenital or acquired deficiency based on the activated partial thromboplastin time (APTT) assay results.
    Device Description
    The assay determines the functional activity of Factor VIII by measuring the degree of prolongation of activated partial thromboplastin time in the presence of a contact activator, thromboplastin, phospholipids and calcium ions. Factor VIII activity is correlated with the prolongation of the clotting time of the Factor VIII deficient plasma to which diluted patient sample has been added.
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    K Number
    K050661
    Device Name
    HEMOSIL FACTOR II DEFICIENT PLASMA
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2005-05-02

    (48 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Why did this record match?
    Product Code :

    GJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemosIL Factor II Deficient Plasma is human plasma immunodepleted of factor II and intended for the in vitro diagnostic quantitative determination of factor II activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.
    Device Description
    HemosIL Factor II Deficient Plasma is human plasma immunodepleted of factor II and intended for the in vitro diagnostic quantitative determination of factor II activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems. Abnormalities of the extrinsic pathway factors are determined by performing a modified prothrombin time (PT) test. Patient plasma is diluted and added to a plasma deficient in factor II. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor II in the patient plasma, interpolated from a calibration curve.
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    K Number
    K043459
    Device Name
    HEMOSIL FACTOR XII DEFICIENT PLASMA
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2005-02-09

    (56 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Why did this record match?
    Product Code :

    GJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemosIL Factor XII Deficient Plasma is human plasma immunodepleted of factor XII and intended for the in vitro diagnostic quantitative determination of factor XII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.
    Device Description
    HemosIL Factor XII Deficient Plasma is human plasma immunodepleted of factor XII and intended for the in vitro diagnostic quantitative determination of factor XII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems. Abnormalities of the intrinsic pathway factors are determined by performing a modified activated partial thromboplastin time (APTT) test. Patient plasma is diluted and added to a plasma deficient in factor XII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor XII in the patient plasma, interpolated from a calibration curve.
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    K Number
    K040362
    Device Name
    DIAPHARMA FACTOR X KIT
    Manufacturer
    DIAPHARMA GROUP, INC.
    Date Cleared
    2004-07-12

    (150 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Why did this record match?
    Product Code :

    GJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DiaPharma Factor X Kit is an in vitro diagnostic test kit for the quantitative determination of Factor X activity in human citrated plasma. Factor X activity is useful for monitoring patients on oral anticoagulant therapy (warfarin) where baseline PT values may be prolonged and INR results are not reliable, such as in OAC patients with lupus inhibitors. The DiaPharma FX kit provides health care providers with a tool for with Tapac Innovelor The DiaPharma Factor X Kit is also useful for screening for factor X deficiencies.
    Device Description
    Not Found
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    K Number
    K034007
    Device Name
    HEMOSIL FACTOR VIII DEFICIENT PLASMA
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2004-02-13

    (51 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Why did this record match?
    Product Code :

    GJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemosIL Factor VIII Deficient Plasma is human plasma immunodepleted of factor VIII and intended for the in vitro diagnostic quantitative determination of factor VIII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.
    Device Description
    HemosIL Factor VIII Deficient Plasma is human plasma immunodepleted of factor VIII and intended for the in vitro diagnostic quantitative determination of factor VIII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems. Abnormalities of the intrinsic pathway factors are determined by performing a modified activated partial thromboplastin time (APTT) test. Patient plasma is diluted and added to a plasma deficient in factor VIII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor VIII in the patient plasma, interpolated from a calibration curve.
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    K Number
    K031829
    Device Name
    HEMOSIL FACTOR IX DEFICIENT PLASMA
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2003-07-31

    (48 days)

    Product Code
    GJT, GGP
    Regulation Number
    864.7290
    Why did this record match?
    Product Code :

    GJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemosIL Factor IX Deficient Plasma is human plasma immunodepleted of Factor IX and intended for the in vitro diagnostic quantitative determination of Factor IX activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.
    Device Description
    HemosIL Factor IX Deficient Plasma is human plasma immunodepleted of Factor IX and intended for the in vitro diagnostic quantitative determination of Factor IX activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems. Abnormalities of the intrinsic pathway factors are determined by performing a modified activated partial thromboplastin time (APTT) test. Patient plasma is diluted and added to a plasma deficient in factor IX. Correction of the of the deficient plasma is proportional to the concentration (% activity) of the factor IX in the patient plasma, interpolated from a calibration curve.
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