BEUDAMED
    Product Code: MJY FDA class 1 21 CFR 862.1660

    Kit, Serological, Negative Control

    Clinical Chemistry

    The Serological Negative Control Kit is a reference reagent used in clinical and diagnostic laboratories as a negative control specimen during serological testing, verifying that the assay does not produce false-positive results in the absence of the target analyte. Classified as a Class 1 device under 21 CFR 862.1660 within the Clinical Chemistry specialty, it is subject only to general controls and is generally exempt from 510(k) premarket notification. It carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    MJY
    Device Class
    FDA class 1
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Review Panel
    MI
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K962399 HEPATITIS NEGATIVE CONTROL

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.