BEUDAMED
    Product Code: DLB FDA class 2 21 CFR 862.3580

    Radioimmunoassay, Lsd (125-I)

    Clinical Toxicology

    The Radioimmunoassay for LSD using iodine-125 radiolabel is a laboratory test system designed to detect and quantify lysergic acid diethylamide (LSD) in patient specimens using radioimmunoassay techniques. It is classified as Class 2, requiring a 510(k) premarket notification prior to marketing. The product code is DLB, regulated under 21 CFR 862.3580, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.

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    510(k)s
    7
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    5
    Years Active
    10

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    Basic Information

    Product Code
    DLB
    Device Class
    FDA class 2
    Regulation Number
    862.3580
    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 7 510(k) clearances via K numbers.

    K Number Device Name
    K961436 ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)
    K955448 EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS
    K955814 CEDIA DAU LSD ASSAY
    K954073 STC DIAGNOSTICS LSD MICRO-PLATE EIA
    K891167 COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT
    K874270 REVISED LABELING FOR LSD TEST KIT
    K860525 ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.