BEUDAMED
    Product Code: DNO FDA class 2 21 CFR 862.3450

    Hemagglutination Inhibition, Gentamicin

    Clinical Toxicology

    The Hemagglutination Inhibition test for Gentamicin is a clinical laboratory immunoassay that measures gentamicin, an aminoglycoside antibiotic, in patient serum using a hemagglutination inhibition format, used for therapeutic drug monitoring to prevent toxicity. It is a Class 2 device requiring 510(k) premarket clearance. The product code is DNO, regulated under 21 CFR 862.3450, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    DNO
    Device Class
    FDA class 2
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K964009 IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS