BEUDAMED
    Product Code: DLX FDA class 2 21 CFR 862.3150

    Hemagglutination Inhibition, Barbiturate

    Clinical Toxicology

    The Hemagglutination Inhibition test for Barbiturate is a laboratory immunoassay that detects barbiturates in patient specimens by measuring the inhibition of red blood cell agglutination, commonly used in clinical toxicology screening panels. It is a Class 2 device requiring 510(k) premarket clearance. The product code is DLX, regulated under 21 CFR 862.3150, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
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    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    DLX
    Device Class
    FDA class 2
    Regulation Number
    862.3150
    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