BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Elecsys PreciControl Anti-HBs

    DI: 04015630910908 · Model: 11876317160 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Elecsys PreciControl Anti-HBs
    Primary DI
    04015630910908
    Version / Model
    11876317160
    Catalog Number
    11876317160
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-10
    Public Version
    5
    Public Version Date
    2019-05-31
    Public Version Status
    Update
    Public Device Record Key
    d7ec2ea4-c81f-4b38-80a8-4571b52f7d10
    Distribution End Date
    2019-05-31

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    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
    LOM Test, hepatitis b (b core, be antigen, be antibody, b core igm)

    GMDN Terms

    Code Name
    41998 Hepatitis B virus surface total antibody IVD, control

    Identifiers

    Type ID
    Primary 04015630910908

    Premarket Submissions

    Submission Number Supplement Number
    P010054 000
    P010054 001
    P010054 007
    P010054 008
    P010054 017

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius