BEUDAMED
    Product Code: GRP FDA class 2 21 CFR 866.3300

    Antisera, All Types, H. Influenza

    Microbiology

    The Antisera, All Types, H. Influenzae is a collection of type-specific antisera used in the laboratory to serotype Haemophilus influenzae isolates, which is important for epidemiological surveillance and clinical management of invasive disease. It is an FDA Class 2 device, subject to moderate risk controls and requiring 510(k) premarket notification. Regulated under 21 CFR 866.3300 with product code GRP in the Microbiology specialty. No special flags apply to this device.

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    510(k)s
    6
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    6
    Years Active
    7

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    Basic Information

    Product Code
    GRP
    Device Class
    FDA class 2
    Regulation Number
    866.3300
    Medical Specialty
    Microbiology
    Review Panel
    MI
    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 6 510(k) clearances via K numbers.

    K Number Device Name
    K884967 BACTIGEN(R) H. INFLUENZAE TYPE B
    K854490 IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES
    K831525 H-FLU B ELISA TEST
    K823348 H. INFLUENZA B ANTISERA FOR CIE
    K821266 BBL DIRECTIGEN MENINGITIS TEST KIT
    K820192 HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM

    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.