BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Elecsys Folate III CalSet

    DI: 04015630922918 · Model: 4874072190 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Elecsys Folate III CalSet
    Primary DI
    04015630922918
    Version / Model
    4874072190
    Catalog Number
    4874072190
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    3
    Public Version Date
    2020-11-02
    Public Version Status
    Update
    Public Device Record Key
    86cbded4-aa43-4122-b989-2ebb79adb00e
    Distribution End Date
    2018-12-18

    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
    JIT CALIBRATOR, SECONDARY

    GMDN Terms

    Code Name
    41931 Folate (vitamin B9) IVD, calibrator

    Identifiers

    Type ID
    Primary 04015630922918

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius