BEUDAMED
    Product Code: CZJ FDA class 2 21 CFR 866.5510

    Igd, Antigen, Antiserum, Control

    Immunology

    The IgD, Antigen, Antiserum, Control test system (product code CZJ) is an in-vitro diagnostic device used in immunology to measure immunoglobulin D (IgD) in serum using antigen-antiserum immunochemical methods, with associated control materials for assay verification. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 866.5510 in the Immunology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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    510(k)s
    8
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    6
    Years Active
    32

    Basic Information

    Product Code
    CZJ
    Device Class
    FDA class 2
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    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 8 510(k) clearances via K numbers.

    K Number Device Name
    K092450 HUMAN IGD KIT FOR USE ON SPAPLUS
    K051299 IGD DIAGNOSTIC TEST KITS
    K002561 SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT
    K913671 HUMAN IGD IMMUNOLOGICAL NL TEST KIT
    K883001 QM300 CALIBRATOR D PACK
    K872834 TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410
    K831956 DETERM. SIZE 72 RADIAL-HUMAN IGD
    K772327 LAS-R HUMAN IGD TEST

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.