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    K Number
    DEN040002
    Device Name
    NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970
    Manufacturer
    PERKINELMER LIFE SCIENCES, INC.
    Date Cleared
    2004-08-24

    (53 days)

    Product Code
    NQL
    Regulation Number
    862.1055
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERKINELMER LIFE SCIENCES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K021541
    Device Name
    NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
    Manufacturer
    PERKINELMER LIFE SCIENCES
    Date Cleared
    2002-10-28

    (171 days)

    Product Code
    JNB, CDR, JJE
    Regulation Number
    862.1555
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERKINELMER LIFE SCIENCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeoGram PKU Tandem Mass Spectrometry Kit is intended for screening for Phenvlketonuria (PKU). It involves the quantitative determination of phenvlalanine, tyrosine and the phenylalanine to tyrosine ratio (Phe/Tyr) in blood specimens dried on filter paper. This will aid in identifying newborns with PKU. It is intended for use by trained, qualified laboratory personnel.
    Device Description
    The assay involves the extraction of dried blood spots with a solution containing stable, isotopically labeled internal standards. The response of each amino acid relative to the isotopically labeled standards in the kit is proportional to their actual concentration. The analysis of the material is performed on a tandem mass spectrometer. Control material contained in the kit allows for verification of performance for the test run.
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