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510(k) Data Aggregation

    K Number
    K132195
    Device Name
    EUROIMMUN ANTI-PLA2R ELISA (IGG)
    Manufacturer
    EUROIMMUN US INC
    Date Cleared
    2014-06-27

    (347 days)

    Product Code
    PGV
    Regulation Number
    866.5780
    Why did this record match?
    Product Code :

    PGV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EUROIMMUN Anti-PLA2R ELISA (IgG) test kit is intended for the qualitative or semiquantitative determination of IgG class autoantibodies against phospholipase A2 receptor (PLA2R) in human serum. It is used as an aid in the diagnosis of primary membranous glomerulonephritis (pMGN), in conjunction with other laboratory and clinical findings.
    Device Description
    The EUROIMMUN Anti-PLA2R ELISA (IgG) consists of a microwell ELISA plate coated with PLA2R antigen, 5 calibrators, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.
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    K Number
    DEN140002
    Device Name
    EUROIMMUN ANTI-PLA2R IFA
    Manufacturer
    EUROIMMUN US
    Date Cleared
    2014-05-29

    (62 days)

    Product Code
    PGV
    Regulation Number
    866.5780
    Why did this record match?
    Product Code :

    PGV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EUROIMMUN Anti-PLA2R IFA is intended for the qualitative determination of IgG class autoantibodies against phospholipase A2 receptor (PLA2R) in human serum. It is used as an aid in the diagnosis of primary membranous glomerulonephritis (pMGN), in conjunction with other laboratory and clinical findings.
    Device Description
    The kit (for 50 determinations) contains an instruction booklet and the following materials: - . Slides, each containing 5x2 BIOCHIPs coated with PLA2R-transfected and controltransfected cells - Fluorescein-labelled anti-human IgG (goat), ready for use (1 x 1.5 ml); - Positive control: anti-PLA2R, ready for use (1 x 0.1 ml) ● - . Negative control: autoantibody negative, ready for use (1 x 0.1 ml) - Salt for PBS pH 7.2 (x2) - Tween 20 (2 x 2.0 ml) . - Embedding medium, ready for use (1 x 3.0 ml) • - . Cover glasses (62 mm x 23 mm) (x12) The EUROIMMUN IFA is an assay for standardized detection of anti-PLA2R antibodies utilized in laboratories familiar with indirect immunofluorescence. The test kit consists of slides, which contain BIOCHIPs coated with PLA2R transfected cells and control-transfected cells, fluorescein-labelled anti-human IgG (goat), a positive control for anti-PLA2R, a negative control. a salt for preparation of PBS. Tween 20, embedding medium, cover glasses and an instruction booklet.
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