BEUDAMED
    Product Code: KQF FDA class 2 21 CFR 864.7375

    Assay, Glutathione Reductase

    Hematology

    This device is a glutathione reductase assay, an in vitro diagnostic test used to measure glutathione reductase enzyme activity in erythrocytes, used in assessing riboflavin (vitamin B2) status and related metabolic disorders. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KQF, regulated under 21 CFR 864.7375 within the Hematology specialty. No special flags apply.

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    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    KQF
    Device Class
    FDA class 2
    Regulation Number
    864.7375
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.