BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ansh Labs DBS Luteinizing Hormone ELISA

    DI: 00853592008325 · Model: AL-190-i · Ansh Labs, LLC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Ansh Labs DBS Luteinizing Hormone ELISA
    Primary DI
    00853592008325
    Version / Model
    AL-190-i
    Catalog Number
    AL-190-i
    Company Name
    Ansh Labs, LLC
    Labeler DUNS
    057752914
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-12
    Public Version
    1
    Public Version Date
    2024-08-20
    Public Version Status
    New
    Public Device Record Key
    dfc3ce90-03a0-4708-ac26-e47598bb390f

    Device Description

    The Dried Blood Spot Luteinizing hormone (LH) immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of Luteinizing hormone (LH). It is intended 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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    54253 Luteinizing hormone (LH) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00853592008325