BEUDAMED
    Product Code: JIP FDA class 2 21 CFR 864.6550

    Blood, Occult, Enzymatic Method, In Urine

    Hematology

    This device is an in vitro diagnostic test that detects occult (hidden) blood in urine using an enzymatic method, used in clinical laboratories to screen for urinary tract conditions, kidney disease, or other disorders that may cause microscopic bleeding. It is classified as FDA Class 2, meaning it poses moderate risk and requires 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is JIP, regulated under 21 CFR 864.6550, and falls within the Hematology medical specialty. This device is eligible for third-party 510(k) review, which allows accredited persons outside FDA to perform the primary review of the submission.

    View on FDA
    510(k)s
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    JIP
    Device Class
    FDA class 2
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    1

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.