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510(k) Data Aggregation

    K Number
    K980574
    Device Name
    AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0
    Manufacturer
    ALFA BIOTECH (UK) LTD.
    Date Cleared
    1998-03-24

    (35 days)

    Product Code
    JLW, JIS
    Regulation Number
    862.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALFA BIOTECH (UK) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AuraFlex TSH-3 is a "third generation" fluorescent enzyme immunoassay for the quantitative determination of thyroid stimulating hormone (TSH) in human serum or plasma using the AuraFlex system. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
    Device Description
    AuraFlex TSH-3 is a "third generation" fluorescent enzyme immunoassay for the quantitative determination of thyroid stimulating hormone (TSH) in human serum or plasma using the AuraFlex system.
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    K Number
    K974505
    Device Name
    AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501
    Manufacturer
    ALFA BIOTECH (UK) LTD.
    Date Cleared
    1998-02-17

    (78 days)

    Product Code
    DBF
    Regulation Number
    866.5340
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALFA BIOTECH (UK) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AuraFlex Ferritin is a fluorescent enzyme immunoassay for the quantitative determination of ferritin in human serum or plasma using the AuraFlex System. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemachromatosis (iron overload) and iron deficiency anemia.
    Device Description
    Fluorescent immunoassay reagents.
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    K Number
    K974027
    Device Name
    AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK
    Manufacturer
    ALFA BIOTECH (UK) LTD.
    Date Cleared
    1998-02-02

    (102 days)

    Product Code
    CDP
    Regulation Number
    862.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALFA BIOTECH (UK) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AuraFlex® FT3 assay is a fluorescent immunoassay for the quantitative determination of free triiodothyronine assay in human serum or plasma using the AuraFlex® System.
    Device Description
    Fluorescent immunoassay reagents.
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