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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ansh Labs MenoCheck picoAMH ELISA (IVD)

    DI: 00853592008127 · Model: AL-124 · 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 MenoCheck picoAMH ELISA (IVD)
    Primary DI
    00853592008127
    Version / Model
    AL-124
    Catalog Number
    AL-124
    Company Name
    Ansh Labs, LLC
    Labeler DUNS
    057752914
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-02
    Public Version
    1
    Public Version Date
    2021-06-10
    Public Version Status
    New
    Public Device Record Key
    41080226-c538-4bdd-b6d0-c9f773d703c7

    Device Description

    The picoAMH ELISA is an enzyme-linked immunosorbent assay (ELISA) for the in vitro quantitative measurement of anti-Müllerian hormone (AMH), also known as Müllerian Inhibiting Substance (MIS), concentrations in human serum. It is intended to be used as an aid in the determination of menopausal status in women between 42 and 62 years of age. This assay should only be used in conjunction with other clinical and laboratory findings and results from this test alone should not be used to make diagnostic or treatment decisions. It is intended for in vitro diagnostic use and for prescription use only.

    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    58413 Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00853592008127

    Customer Contacts

    Phone
    (281) 404-0260
    Email
    [email protected]