BEUDAMED
    Product Code: CZS FDA class 1 21 CFR 866.5765

    Retinol-Binding Protein, Antigen, Antiserum, Control

    Immunology

    This is a reagent system used to detect and measure retinol-binding protein, the serum transport protein for vitamin A, in clinical specimens. The kit comprises antigen, antiserum, and control components intended for immunochemical analysis. It is classified as FDA Class 1, the lowest risk category, subject to general controls only without requiring premarket notification or approval. The product code is CZS, regulated under 21 CFR 866.5765, within the Immunology specialty.

    View on FDA
    510(k)s
    3
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    2
    Years Active
    12

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    Basic Information

    Product Code
    CZS
    Device Class
    FDA class 1
    Regulation Number
    866.5765
    Medical Specialty
    Immunology
    Review Panel
    IM
    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 3 510(k) clearances via K numbers.

    K Number Device Name
    K973189 RETINOL BINDING PROTEIN RBP RID KIT
    K955881 RETINOL BINDING RID KIT
    K853261 LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS)

    FEI Numbers

    This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.