BEUDAMED
    Product Code: JNS FDA class 1 21 CFR 862.1575

    Stannous Chloride - Hydrazine, Phospholipids

    Clinical Chemistry

    The Stannous Chloride-Hydrazine, Phospholipids test is a clinical chemistry diagnostic reagent used to measure phospholipids in serum or plasma, employing stannous chloride and hydrazine as chemical reagents in the assay procedure. Phospholipid levels are relevant to the assessment of lipid metabolism disorders and certain hepatic and cardiovascular conditions. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JNS and is regulated under 21 CFR 862.1575, within the Clinical Chemistry medical specialty.

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    FEI Numbers
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    Years Active
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    Basic Information

    Product Code
    JNS
    Device Class
    FDA class 1
    Regulation Number
    862.1575
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting