BEUDAMED
    Product Code: QBF FDA class 2 21 CFR 862.3700

    Test, Propoxyphene, Over The Counter

    Clinical Toxicology

    The Test, Propoxyphene, Over The Counter is an in vitro diagnostic test for the qualitative detection of propoxyphene in human urine, intended for over-the-counter use as the first step in a two-step process to provide consumers with information concerning the presence or absence of propoxyphene in a urine sample. It is classified as a Class 2 device under regulation 862.3700, requiring 510(k) premarket notification and eligible for third-party review, falling within the Clinical Toxicology (TX) medical specialty. The product code is QBF. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    QBF
    Device Class
    FDA class 2
    Regulation Number
    862.3700
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    The propoxyphene test is an in vitro diagnostic test for the qualitative detection of propoxyphene in human urine. The test is intended for over-the-counter use as the first step in a two step process to provide consumers with information concerning the presence or absence of propoxyphene in a urine sample.

    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
    K210327 First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup

    FEI Numbers

    This FDA classification entry is associated with 46 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 46 registration numbers. Click on an entry to view related FDA registrations.