BEUDAMED
    Product Code: JMB FDA class 2 21 CFR 864.7360

    Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase

    Hematology

    This device is a visual semi-quantitative colorimetric test system used to screen for glucose-6-phosphate dehydrogenase (G6PD) deficiency, an X-linked enzyme disorder that predisposes affected individuals to hemolytic anemia when exposed to certain drugs, foods, or infections. It is classified as FDA Class 2, requiring 510(k) premarket notification, under 21 CFR 864.7360, within the Hematology medical specialty. This device is eligible for third-party 510(k) review.

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

    Basic Information

    Product Code
    JMB
    Device Class
    FDA class 2
    Regulation Number
    864.7360
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    1

    Device Characteristics

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

    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
    K850680 ENCORE FERRITIN REAGENT