BEUDAMED
    Product Code: KLO FDA class 2 21 CFR 862.3450

    Enzymatic Radiochemical Assay, Gentamicin

    Clinical Toxicology

    The Gentamicin Enzymatic Radiochemical Assay is an in vitro diagnostic test used in clinical toxicology laboratories to measure gentamicin concentrations in patient serum, supporting therapeutic drug monitoring to optimize dosing and minimize nephrotoxic and ototoxic risk from this aminoglycoside antibiotic. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KLO and the applicable regulation is 21 CFR 862.3450 in the Clinical Toxicology specialty. This device is eligible for third-party review.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    KLO
    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
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    Summary Malfunction Reporting