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510(k) Data Aggregation

    K Number
    K973143
    Device Name
    UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA
    Date Cleared
    1997-09-25

    (34 days)

    Product Code
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIVERSAL REAGENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This product is intended for use in the quantitative determination of factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, XII. Factor immunodeficient plasma XII is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors.
    Device Description
    Factor deficient plasma to be free of antigen of Factor XII utilized in in vitro diagnostic use. Factor immunodeficient plasma XII is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors.
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    K Number
    K972286
    Device Name
    FACTOR DEFICIENT PLASMAS - FACTOR XI (11)
    Date Cleared
    1997-07-14

    (25 days)

    Product Code
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIVERSAL REAGENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This product is intended for use in the quantitative determination of Indicated use factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, XI.
    Device Description
    Factor deficient plasma to be free of antigen of Factor XI utilized in in vitro diagnostic use. Factor immunodeficient plasma XI is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors.
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    K Number
    K972288
    Device Name
    FACTOR DEFICIENT PLASMAS - FACTOR IX (9)
    Date Cleared
    1997-07-14

    (25 days)

    Product Code
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIVERSAL REAGENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This product is intended for use in the quantitative determination of factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, IX.
    Device Description
    Factor Deficient Coagulation Plasma Factor - IX (nine) is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors.
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    K Number
    K970593
    Device Name
    UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA
    Date Cleared
    1997-04-25

    (66 days)

    Product Code
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIVERSAL REAGENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indicated use - Factor deficient plasma, Factor - VIII is a human plasma immunodepleted of the indication and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay.
    Device Description
    Factor deficient plasma to be free of antigen of Factor VIII utilized in in vitro diagnostic use.
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    K Number
    K970607
    Device Name
    UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA
    Date Cleared
    1997-04-25

    (66 days)

    Product Code
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIVERSAL REAGENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indicated use - Factor deficient plasma, Factor - VII is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay.
    Device Description
    Factor deficient coagulation plasma - VII is a human plasma immunodepleted of the specific factor and intended for use in in vitro diagnostic use.
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    K Number
    K964270
    Device Name
    UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA
    Date Cleared
    1996-12-18

    (54 days)

    Product Code
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIVERSAL REAGENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indicated use - Factor deficient plasma, Factor - V is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay. Environment of use: Clinical laboratories
    Device Description
    Factor deficient plasma to be free of antigen of Factor V utilized in in vitro diagnostic use
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    K Number
    K964459
    Device Name
    UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA
    Date Cleared
    1996-12-18

    (41 days)

    Product Code
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIVERSAL REAGENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indicated use - Factor deficient plasma, Factor - X is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay.
    Device Description
    Factor deficient plasma to be free of antigen of Factor X utilized in in vitro diagnostic use.
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    K Number
    K961929
    Device Name
    FACTOR DEFICIENT PLASMA
    Date Cleared
    1996-10-10

    (146 days)

    Product Code
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIVERSAL REAGENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indicated use - Factor deficient plasma, Factor - II, V, VII, VIII, IX, XI, XII, XII, is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay. Factor VIII is human plasma and bovine material.
    Device Description
    Factor deficient plasma to be free of antigen of Factor II, V, VII, VIII, IX, X, XI, XII, respectively, utilized in in vitro diagnostic use.
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