BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KIT CTM MTB 48T EXPT-IVD

    Reg #: 2243471 · FEI: 2243471 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    1

    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

    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
    Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis NDZ

    Proprietary Names

    KIT CTM MTB 48T EXPT-IVD KIT COBAS 6800/8800 MTB RMC IVD KIT COBAS 6800/8800 MAI RMC IVD KIT COBAS 6800/8800 MAI 384T KIT COBAS 6800/8800 MTB-RIF/INH RMC IVD KIT COBAS 6800/8800 MTB 384T KIT COBAS 6800/8800 MTB-RIF/INH 72T IVD AMPLICOR® Respiratory Specimen Preparation Kit (100 Tests) KIT COBAS 58/68/8800 MAI RMC IVD KIT COBAS 58/68/8800 MTB-RIF/INH RMC KIT COBAS 58/68/8800 MTB RMC IVD KIT COBAS 58/68/8800 MTB-RIF/INH 192T KIT COBAS 58/68/8800 MAI 384T KIT C-TAQ MTB 96T JPN-IVD KIT COBAS 58/68/8800 MTB 384T KIT CTM48 MAI 96 TESTS JPN-IVD

    Establishment Types

    Manufacture Device in the United States for Export Only