BEUDAMED
    Product Code: DAN FDA class 2 21 CFR 866.5350

    Fibrinopeptide A, Antigen, Antiserum, Control

    Immunology

    This is an immunological reagent kit for detecting fibrinopeptide A, a small peptide cleaved from fibrinogen by thrombin during coagulation, serving as a marker of active clot formation. The kit includes antigen, antiserum, and control components for in vitro immunoassay testing in clinical laboratories. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DAN, regulated under 21 CFR 866.5350, within the Immunology specialty.

    View on FDA
    510(k)s
    3
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    3
    Years Active
    6

    Basic Information

    Product Code
    DAN
    Device Class
    FDA class 2
    Regulation Number
    866.5350
    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 3 510(k) clearances via K numbers.

    K Number Device Name
    K884496 RIA/MAT FPA TEST KIT
    K854384 ASSERACHROM FPA KIT
    K821151 RIA-QUANT FPA TEST KIT