BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Elecsys AMH

    DI: 04015630946211 · Model: 06331076160 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Elecsys AMH
    Primary DI
    04015630946211
    Version / Model
    06331076160
    Catalog Number
    06331076160
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-02-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    1e85b094-bf3b-43e5-8443-6ddf70f65c21

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    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
    PQO Anti-Müllerian hormone test system

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 04015630946211

    Premarket Submissions

    Submission Number Supplement Number
    DEN150057 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius