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    FDA UDI In Commercial Distribution 🇺🇸 United States

    AutoDELFIA Neonatal hTSH kit

    DI: 06438147179596 · Model: B032-02C · Wallac Oy
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AutoDELFIA Neonatal hTSH kit
    Primary DI
    06438147179596
    Version / Model
    B032-02C
    Catalog Number
    B032-02C
    Company Name
    Wallac Oy
    Labeler DUNS
    540156544
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-02-02
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    2156f99f-9445-40d5-80aa-d23441a4bccf

    Device Description

    Time-resolved fluoroimmunoassay for the quantitative determination of human thyrotropin (thyroid stimulating hormone - hTSH) in dried blood.

    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
    JLW Radioimmunoassay, Thyroid-Stimulating Hormone

    GMDN Terms

    Code Name
    59221 Neonatal thyroid stimulating hormone (neonatal TSH) IVD, kit, fluorescent immunoassay

    Identifiers

    Type ID
    Primary 06438147179596

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius