BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AccuDiag™ Estradiol ELISA

    DI: 00850054026682 · Model: DACD2046-15 · Diagnostic Automation, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    AccuDiag™ Estradiol ELISA
    Primary DI
    00850054026682
    Version / Model
    DACD2046-15
    Catalog Number
    2046-15
    Company Name
    Diagnostic Automation, Inc.
    Labeler DUNS
    878252071
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-27
    Public Version
    1
    Public Version Date
    2026-02-04
    Public Version Status
    New
    Public Device Record Key
    f3b4f8bf-77b5-4cd8-ac20-6c1dcd7d1b1e

    Device Description

    AccuDiag™ Estradiol ELISA Kit A collection of reagents and other associated materials intended to be used for the quantitative measurement of the estrogen hormone estradiol in a clinical specimen, using an enzyme immunoassay (EIA) method.

    Device Characteristics

    Single Use
    Yes
    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
    CHP Radioimmunoassay, Estradiol

    GMDN Terms

    Code Name
    54152 Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00850054026682

    Customer Contacts

    Phone
    8185913030
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 96 tests

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius