BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems

    DI: 00875197005776 · Model: 07460066190 · Roche Molecular Systems, Inc.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems
    Primary DI
    00875197005776
    Version / Model
    07460066190
    Catalog Number
    07460066190
    Company Name
    Roche Molecular Systems, Inc.
    Labeler DUNS
    071674100
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-04-26
    Public Version
    2
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    48ebbe30-114c-4eab-91f4-077a3aed4ad9

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MKZ DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA
    LSL DNA-REAGENTS, NEISSERIA
    OOI real time Nucleic acid amplification system

    GMDN Terms

    Code Name
    50409 Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 00875197005776