BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KIT COBAS 68/88 HIV-1/HIV-2 QUAL RMC IVD

    Reg #: 3004141078 · FEI: 3004141078 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ROCHE MOLECULAR SYSTEMS, INC.
    Registration Number
    3004141078
    FEI Number
    3004141078
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4300 HACIENDA DRIVE
    City
    PLEASANTON
    State
    CA
    ZIP
    94588
    Country
    US

    Regulatory Submissions

    PMA Number
    BP190360

    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
    Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test QST

    Proprietary Names

    KIT COBAS 68/88 HIV-1/HIV-2 QUAL RMC IVD cobas® HIV-1/HIV-2 Qualitative KIT C68/88 HIV-1/HIV-2 QUAL 96T IVD KIT COBAS 58/68/8800 HIV-1/2 192T IVD cobas® HIV-1/HIV-2 Qualitative Control Kit cobas® HIV-1/HIV-2 KIT COBAS 58/68/8800 HIV-1/2 RMC KIT C58/68/88 HIV-1/HIV-2 QUAL 192T IVD cobas® HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas® 5800/6800/8800 Systems

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility