BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    cobas® 4800 System Control Diluent Kit

    DI: 00875197003215 · 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 System Control Diluent Kit
    Primary DI
    00875197003215
    Version / Model
    1.0
    Catalog Number
    05235847190
    Company Name
    Roche Molecular Systems, Inc.
    Labeler DUNS
    071674100
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-03-31
    Public Version
    3
    Public Version Date
    2021-02-03
    Public Version Status
    Update
    Public Device Record Key
    a158ec12-b3be-4bcd-ba9b-b9705d263aed

    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
    OOI real time Nucleic acid amplification system
    MKZ DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA

    GMDN Terms

    Code Name
    52521 Nucleic acid extraction/isolation kit IVD

    Identifiers

    Type ID
    Primary 00875197003215