BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KIT COBAS 4800 F2F5 AMP/DET 96T IVD

    Reg #: 2243471 · FEI: 2243471 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ROCHE MOLECULAR SYSTEMS, INC.
    Registration Number
    2243471
    FEI Number
    2243471
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1080 US Highway 202 South
    City
    Branchburg
    State
    NJ
    ZIP
    08876
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172913

    Owner / Operator

    Firm Name
    Roche Diagnostics Operations Inc.
    Operator Number
    9039767
    Address
    9115 Hague Road
    City
    Indianapolis
    State
    IN
    Postal Code
    46250
    Country
    US

    Products

    Device Name Product Code
    Test, Factor Ii G20210a Mutations, Genomic Dna Pcr NPR
    Test, Factor V Leiden Mutations, Genomic Dna Pcr NPQ

    Proprietary Names

    KIT COBAS 4800 F2F5 AMP/DET 96T IVD cobas® Factor II and Factor V Test SET CD-ROM C4800 F2F5 PCR V1

    Establishment Types

    Manufacture Medical Device