BEUDAMED
    Product Code: GNB FDA class 2 21 CFR 866.3660

    Antisera, All Types, Shigella Spp.

    Microbiology

    The Antisera for All Types of Shigella Species are serotyping reagents used in microbiology laboratories to identify and classify Shigella isolates responsible for bacterial dysentery (shigellosis), a significant cause of diarrheal disease worldwide. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. The product code is GNB, regulated under 21 CFR 866.3660 in the Microbiology specialty.

    View on FDA
    510(k)s
    41
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    4
    Years Active
    14

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    Basic Information

    Product Code
    GNB
    Device Class
    FDA class 2
    Regulation Number
    866.3660
    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 41 510(k) clearances via K numbers.

    K Number Device Name
    K961537 SAS SHIGELLA SONNEI FORM II ANTISERUM
    K961559 SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM
    K961558 SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM
    K961556 SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM
    K961554 SAS SHIGELLA BOYDII TYPE 10 ANTISERUM
    K961553 SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM
    K961551 SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM
    K961549 SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM
    K961548 SAS SHIGELLA BOYDII TYPE 15 ANTISERUM
    K961547 SAS SHIGELLA BOYDII TYPE 14 ANTISERUM
    K961546 SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM
    K961543 SAS SHIGELLA BOYDII TYPE 9 ANTISERUM
    K961542 SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUM
    K961541 SAS SHIGELLA BOYDII TYPE 8 ANTISERUM
    K961540 SAS SHIGELLA SONNEI GROUP D ANTISERUM
    K961539 SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM
    K961538 SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM
    K961535 SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM
    K961534 SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML)
    K961533 SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM
    K961532 SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM
    K961531 SAS SHIGELLA BOYDII TYPE 13 ANTISERUM
    K961529 SAS SHIGELLA BOYDII TYPE 12 ANTISERUM
    K961528 SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML)
    K953321 SAS SHIGELLA DYSENTERIAE TYPE 3 ANTISERUM
    K953320 SAS SHIGELLA DYSENTERIAE TYPE 4 ANTISERUM
    K953319 SAS SHIGELLA DYSENTERIAE TYPE 5 ANTISERUM
    K953318 SAS SHIGELLA DYSENTERIAE TYPE 6 ANTISERUM
    K953317 SAS SHIGELLA DYSENTERIAE TYPE 7 ANTISERUM
    K953316 SAS SHIGELLA DYSENTERIAE GROUP A (1-7) ANTISERUM
    K953329 SAS SHIGELLA BOYDII GROUP C2 ANTISERUM
    K953328 SAS SHIGELLA BOYDII TYPE 7 ANTISERUM
    K953327 SAS SHIGELLA BOYDII TYPE 6 ANTISERUM
    K953326 SAS SHIGELLA BOYDII TYPE 5 ANTISERUM
    K953325 SAS SHIGELLA BOYDII TYPE 4 ANTISERUM
    K953324 SAS SHIGELLA BOYDII TYPE 3 ANTISERUN
    K953323 SAS SHIGELLA BOYDII TYPE 2 ANTISERUM
    K953322 SAS SHIGELLA BOYDII TYPE 1 ANTISERUM
    K895461 WELLCOLEX COLOUR SHIGELLA TEST ZC51
    K880752 PHADEBACT SHIGELLA TEST
    K821337 SHIGELLA I.D.

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.