BEUDAMED
    Product Code: DJJ FDA class 2 21 CFR 862.3640

    Fluorometry, Morphine

    Clinical Toxicology

    The Fluorometric Morphine test is a laboratory assay that uses fluorometric measurement to detect and quantify morphine in biological specimens, supporting clinical pain management monitoring and toxicological investigations for opioid exposure. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3640 within the Clinical Toxicology specialty. The device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    DJJ
    Device Class
    FDA class 2
    Regulation Number
    862.3640
    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
    K013124 MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.