BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AutoDELFIA hAFP kit

    DI: 06438147321322 · Model: B079-212 · Wallac Oy
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AutoDELFIA hAFP kit
    Primary DI
    06438147321322
    Version / Model
    B079-212
    Catalog Number
    B079-212
    Company Name
    Wallac Oy
    Labeler DUNS
    540156544
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-24
    Public Version
    4
    Public Version Date
    2019-03-21
    Public Version Status
    Update
    Public Device Record Key
    20a694f7-f6b6-4f8b-88b8-abe76859a464

    Device Description

    Time-resolved fluoroimmunoassay for the quantitative determination of human alphafetoprotein (hAFP)

    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
    LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    GMDN Terms

    Code Name
    54060 Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

    Identifiers

    Type ID
    Primary 06438147321322

    Premarket Submissions

    Submission Number Supplement Number
    P970037 000
    P970037 009
    P970037 010
    P970037 011

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius