BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    cobas x480 system

    Reg #: 3003795116 · FEI: 3003795116 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    29
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ROCHE DIAGNOSTICS INTERNATIONAL LTD.
    Registration Number
    3003795116
    FEI Number
    3003795116
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    FORRENSTRASSE 2
    City
    ROTKREUZ Zug
    Country
    CH

    Regulatory Submissions

    PMA Number
    P100020

    Owner / Operator

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

    US Agent

    Business Name
    Roche Diagnostics Operations Inc
    Contact Name
    Brian Frazier
    Address
    9115 Hague Rd
    City
    Indianapolis
    State
    IN
    ZIP
    46256
    Country
    US
    Email
    [email protected]
    Phone
    317 5214603

    Products

    Device Name Product Code
    Kit, Dna Detection, Human Papillomavirus MAQ

    Proprietary Names

    cobas x480 system cobas z480 Analyzer cobas HPV Test cobas 4800 System Sample Preparation Kit, 960 Tests KIT cobas 4800 SYS SAMPLE PREP 240T IVD cobas 4800 System Wash Buffer Kit, 960 Tests SW COBAS 4800 FSE TOOLS CD 3 KIT cobas 4800 HPV AMP/DET 240T US-IVD cobas 4800 HPV Amplification/Detection Kit, 240 Tests SW OSWIN7 RECSYS RP5800-C4800 V2.1.1 DVD KIT cobas 4800 SYS LIQ CYT PREP 240T IVD cobas 4800 HPV Amplification/Detection Kit, 960 Tests KIT cobas 4800 HPV CONTROLS 10 SETS IVD SW cobas 4800 UDF v2 CD cobas 4800 System Sample Preparation Kit, 240 Tests KIT cobas 4800 SYS SAMPLE PREP 960T IVD SW C4800 HPV AP v2.1 CD cobas Sample Prep Buffer cobas 4800 System cobas HPV AP software KIT cobas 4800 HPV AMP/DET 960T US-IVD cobas 4800 System Liquid Cytology Preparation Kit, 240 Tests KIT COBAS SAMPLE PREP BUFFER 480T IVD cobas 4800 System Liquid Cytology Preparation Kit, 960 Tests cobas 4800 System Wash Buffer Kit, 240 Tests KIT cobas 4800 SYS LIQ CYT PREP 960T IVD cobas 4800 HPV Controls Kit, 10 Sets KIT cobas 4800 SYS WASH BUFFER 960T IVD KIT cobas 4800 SYS WASH BUFFER 240T IVD cobas z480 system

    Establishment Types

    Manufacture Medical Device