BEUDAMED
    Product Code: GNA FDA class 1 21 CFR 866.3255

    Antisera, All Types, Escherichia Coli

    Microbiology

    The Antisera for All Types of Escherichia Coli are typing antisera used in microbiology to serologically classify E. coli isolates, assisting in the investigation of foodborne illness, gastrointestinal infections, and urinary tract infections. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls without a premarket submission requirement. The product code is GNA, regulated under 21 CFR 866.3255 in the Microbiology specialty.

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    510(k)s
    12
    FEI Numbers
    13
    Registration Numbers
    13
    Unique Applicants
    10
    Years Active
    21

    Basic Information

    Product Code
    GNA
    Device Class
    FDA class 1
    Regulation Number
    866.3255
    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 12 510(k) clearances via K numbers.

    K Number Device Name
    K071799 MODIFICATION TO BIOSTAR OIA SHIGATOX
    K031367 DUOPATH VEROTOXINS GLISA TEST
    K993401 DRYSPOT E.COLI 0157 KIT
    K981734 VTEC-RPLA SEIKEN
    K962028 WELLCOLEX E-COLI OI57 ZC60
    K953362 PREMIER EHEC
    K950167 PREMIER EHEC
    K933457 RIM E.COLI 0157:H7 LATEX TEST
    K903714 E. COLI 0157 LATEX TEST
    K884026 ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT
    K874288 PHADEBACT ETEC-LT TEST
    K855234 DIAGNOSTIC REAGENT VET-RPLA

    FEI Numbers

    This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.