BEUDAMED
    Product Code: GJH FDA class 1 21 CFR 864.1850

    Stain, Reticulocyte

    Hematology

    Stain, Reticulocyte (product code GJH) is a supravital hematology staining reagent used to identify reticulocytes, immature red blood cells containing residual RNA, in blood smears for the assessment of erythropoietic activity and monitoring of anemia treatment response. This device is classified as FDA Class 1, the lowest risk category, subject to general controls only and not requiring premarket notification. Regulated under 21 CFR 864.1850 in the Hematology specialty (HE), this device is GMP exempt.

    View on FDA
    510(k)s
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    GJH
    Device Class
    FDA class 1
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    4

    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
    K790042 STAIN, HEMASTAIN RETIC

    FEI Numbers

    This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.