BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    B.R.A.H.M.S PCT sensitive KRYPTOR

    DI: 04260157638259 · Model: 825.050 · B.R.A.H.M.S GmbH
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    B.R.A.H.M.S PCT sensitive KRYPTOR
    Primary DI
    04260157638259
    Version / Model
    825.050
    Company Name
    B.R.A.H.M.S GmbH
    Labeler DUNS
    343844205
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-17
    Public Version
    4
    Public Version Date
    2023-05-25
    Public Version Status
    Update
    Public Device Record Key
    89009b8c-f36c-4804-8d9d-1d7bc2a8abde

    Device Characteristics

    Single Use
    No
    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
    PMT Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
    NTM Antigen, Inflammatory Response Marker, Sepsis
    PRI Procalcitonin Assay

    GMDN Terms

    Code Name
    54313 Procalcitonin (PCT) IVD, kit, fluorescent immunoassay

    Identifiers

    Type ID
    Primary 04260157638259

    Premarket Submissions

    Submission Number Supplement Number
    K171338 000