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    FDA UDI In Commercial Distribution 🇺🇸 United States

    DBC Estrone ELISA

    DI: B261CANE4208PK0 · Model: CAN-E-420-8PK · Diagnostics Biochem Canada Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DBC Estrone ELISA
    Primary DI
    B261CANE4208PK0
    Version / Model
    CAN-E-420-8PK
    Catalog Number
    CAN-E-420-8PK
    Company Name
    Diagnostics Biochem Canada Inc
    Labeler DUNS
    207718438
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-10
    Public Version
    1
    Public Version Date
    2022-11-18
    Public Version Status
    New
    Public Device Record Key
    61dbf540-a58e-4cee-b7c1-cbfe96968df1

    Device Description

    For the quantitative measurement of Estrone in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use.

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CGF Radioimmunoassay, Estrone

    GMDN Terms

    Code Name
    54164 Estrone (oestrone) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary B261CANE4208PK0

    Customer Contacts

    Phone
    1-519-681-8731
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius