BEUDAMED
    Product Code: NGM FDA unclassified

    Test, Phencyclidine (Pcp), Over The Counter

    Unknown

    The Test, Phencyclidine (PCP), Over The Counter (product code NGM) is an in vitro diagnostic test for the qualitative analysis of phencyclidine (PCP) in urine specimens, designed for consumer home use in drug screening. The device class is listed as "U" (unclassified), meaning it has not yet been formally classified by the FDA, and it lacks an assigned regulation number or medical specialty. The device is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    37
    Registration Numbers
    37
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    NGM
    Device Class
    FDA unclassified
    Medical Specialty
    Unknown
    Review Panel
    TX
    Submission Type
    1

    Device Characteristics

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

    Definition

    The phencyclidine test is an in vitro diagnostic test for the qualitative analysis of phencyclidine in human urine.

    Unclassified Reason

    1

    FEI Numbers

    This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.