BEUDAMED
    Product Code: GGF FDA class 2 21 CFR 864.7500

    Acid Hematin

    Hematology

    Acid Hematin (product code GGF) is a hematology reagent used in photometric methods for determining hemoglobin concentration in blood samples, functioning as part of the Sahli acid hematin technique. This device is classified as FDA Class 2, indicating moderate risk, and does not require premarket notification under the current classification. Regulated under 21 CFR 864.7500 in the Hematology specialty (HE), this device carries no flags for implantation, life support, GMP exemption, or third-party review.

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    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    GGF
    Device Class
    FDA class 2
    Regulation Number
    864.7500
    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 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.