BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AMH Control

    DI: 17350066140579 · Model: 660-20 · Fujirebio Diagnostics AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AMH Control
    Primary DI
    17350066140579
    Version / Model
    660-20
    Company Name
    Fujirebio Diagnostics AB
    Labeler DUNS
    357159631
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-04-25
    Public Version
    1
    Public Version Date
    2019-05-03
    Public Version Status
    New
    Public Device Record Key
    3d55136a-f9f3-4313-b237-d6a99c669abe

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJY Multi-Analyte Controls, All Kinds (Assayed)

    GMDN Terms

    Code Name
    58411 Anti-Mullerian hormone (AMH) IVD, control

    Identifiers

    Type ID
    Primary 17350066140579

    Customer Contacts

    Phone
    +4631857030
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Number of Bottles per Kit = 3; Unit of Measure = 2mLs

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    18 – 25 Degrees Celsius