BEUDAMED
    Product Code: DEX FDA class 1 21 CFR 866.5420

    Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control

    Immunology

    This is an immunological reagent kit for detecting alpha-1-B-glycoprotein, a plasma glycoprotein belonging to the alpha-1 fraction of serum proteins, including antigen, antiserum, and control components for clinical laboratory immunoassay applications. It is classified as FDA Class 1, the lowest risk category, subject to general controls only and not requiring premarket notification or approval. The product code is DEX, regulated under 21 CFR 866.5420, within the Immunology specialty.

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    510(k)s
    5
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    5
    Years Active
    6

    Basic Information

    Product Code
    DEX
    Device Class
    FDA class 1
    Regulation Number
    866.5420
    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 5 510(k) clearances via K numbers.

    K Number Device Name
    K823765 ANTI SERA TO HUMAN OROSCOMUCOID
    K801909 LSA 290 ASSAY REAGENTS/NEPHELOMETRIC
    K791341 HUMAN ALPHA, ACID GLYCOPROTEIN
    K781023 ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU
    K760143 SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.