BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    cobas® 4800 CT/NG Test

    DI: 00875197003314 · 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
    00875197003314
    Version / Model
    1.0
    Catalog Number
    05235944190
    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
    b164108d-933b-4520-a906-357d63282b20
    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
    LSL DNA-REAGENTS, NEISSERIA
    MKZ DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA
    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 00875197003314