BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    cobas® 4800 CT/NG Test

    DI: 00875197003307 · Model: 1.0 · Roche Molecular Systems, Inc.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    cobas® 4800 CT/NG Test
    Primary DI
    00875197003307
    Version / Model
    1.0
    Catalog Number
    05235936190
    Company Name
    Roche Molecular Systems, Inc.
    Labeler DUNS
    071674100
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-03-31
    Public Version
    4
    Public Version Date
    2021-02-05
    Public Version Status
    Update
    Public Device Record Key
    e68a29fa-7431-45fd-b227-61db08e3944f
    Distribution End Date
    2021-02-01

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    OOI real time Nucleic acid amplification system
    LSL DNA-REAGENTS, NEISSERIA
    MKZ DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00875197003307