BEUDAMED
    Product Code: GIL FDA class 2 21 CFR 864.7340

    Plasma, Fibrinogen Control

    Hematology

    Plasma, Fibrinogen Control (product code GIL) is a quality control plasma preparation used to verify the performance of fibrinogen determination assays in hematology laboratories, ensuring accurate measurement of this key coagulation protein. 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 864.7340 in the Hematology specialty (HE), this device carries no special regulatory flags.

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    510(k)s
    8
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    5
    Years Active
    13

    Basic Information

    Product Code
    GIL
    Device Class
    FDA class 2
    Regulation Number
    864.7340
    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 8 510(k) clearances via K numbers.

    K Number Device Name
    K962407 N/T PROTEIN CONTROL PY
    K946265 FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3
    K946193 FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3
    K935598 PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2
    K951012 N/T PROTEIN CONTROL PY
    K934741 LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2
    K915462 FIBRINOGEN CONTROL
    K833352 GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.