BEUDAMED
    Product Code: DIQ FDA class 2 21 CFR 862.3640

    Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep.

    Clinical Toxicology

    The Radioimmunoassay for Morphine (3-H) using Goat Antibody Ammonium Sulfate Separation is a quantitative laboratory test employing radiolabeled morphine and goat-derived antibodies with ammonium sulfate precipitation to measure morphine levels in biological specimens for pain management monitoring or toxicology screening. 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. This device is eligible for third-party 510(k) 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
    DIQ
    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
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    Summary Malfunction Reporting