BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CAPILLARYS Hb A1c

    DI: 03607360020159 · Model: 2015 · SEBIA
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CAPILLARYS Hb A1c
    Primary DI
    03607360020159
    Version / Model
    2015
    Catalog Number
    2015
    Company Name
    SEBIA
    Labeler DUNS
    276801933
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-24
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    13fe4aa9-2cc7-4edb-8e08-b64fe889fd4f

    Device Description

    Device for the detection and quantitation of HbA1c in whole blood using capillary electrophoresis

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
    JIS Calibrator, Primary
    LCP Assay, Glycosylated Hemoglobin

    GMDN Terms

    Code Name
    53313 Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography

    Identifiers

    Type ID
    Primary 03607360020159

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius