BEUDAMED
    Product Code: DJP FDA class 2 21 CFR 862.3100

    Radioimmunoassay, Amphetamine

    Clinical Toxicology

    The Radioimmunoassay for Amphetamine is a quantitative laboratory test that uses radiolabeled amphetamine and antibody-based methodology to measure amphetamine levels in biological specimens, supporting drug of abuse screening and forensic toxicology. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3100 within the Clinical Toxicology specialty. The device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    9
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    5
    Years Active
    14

    Research product code DJP in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    DJP
    Device Class
    FDA class 2
    Regulation Number
    862.3100
    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

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 9 510(k) clearances via K numbers.

    K Number Device Name
    K960526 PRIMIDONE EIA TEST
    K913866 URINE AMPHETAMINE DIRECT RIA KIT (I-125)
    K912755 ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE
    K882228 REVISED DOUBLE ANTIBODY AMPHETAMINE
    K881817 ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES
    K854009 ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP
    K830482 ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE
    K823212 ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE
    K812986 AGGLUTEX AMPHETAMINE TEST KIT