BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Xpert Vaginal/Endocervical Specimen Collection Kit

    Reg #: 3004530258 · FEI: 3004530258 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CEPHEID
    Registration Number
    3004530258
    FEI Number
    3004530258
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    904 CARIBBEAN DRIVE
    City
    Sunnyvale
    State
    CA
    ZIP
    94089
    Country
    US

    Regulatory Submissions

    510(k) Number
    K151565

    Owner / Operator

    Firm Name
    CEPHEID
    Operator Number
    9062742
    Address
    904 CARIBBEAN DRIVE, --
    City
    Sunnyvale
    State
    CA
    Postal Code
    94089
    Country
    US
    Correspondent
    Somesh Lalithraj

    Products

    Device Name Product Code
    Real Time Nucleic Acid Amplification System OOI
    Trichomonas Vaginalis Nucleic Acid Amplification Test System OUY

    Proprietary Names

    Xpert Vaginal/Endocervical Specimen Collection Kit Xpert TV Xpert Urine Specimen Collection kit

    Establishment Types

    Manufacture Medical Device