BEUDAMED
    Product Code: DIW FDA class 2 21 CFR 862.3620

    Hemagglutination Inhibition, Methadone

    Clinical Toxicology

    The Hemagglutination Inhibition Methadone test is a laboratory assay that uses hemagglutination inhibition methodology to detect or measure methadone in biological specimens, supporting clinical monitoring of patients receiving methadone maintenance therapy for opioid dependence. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3620 within the Clinical Toxicology specialty. The device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    4
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    4
    Years Active
    19

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    Basic Information

    Product Code
    DIW
    Device Class
    FDA class 2
    Regulation Number
    862.3620
    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 4 510(k) clearances via K numbers.

    K Number Device Name
    K950182 URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE
    K930845 ROCHE ABUSCREEN ONTRAK FOR METHADONE
    K801509 HI-M-TEST FOR METHADONE TEST #2
    K760075 KIT, METHADONE (TOXI-PAK IMMUNO HI)