BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    uTASWako DCP

    DI: 00856626006120 · Model: 995-60701 · FUJIFILM WAKO PURE CHEMICAL CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    uTASWako DCP
    Primary DI
    00856626006120
    Version / Model
    995-60701
    Catalog Number
    995-60701
    Company Name
    FUJIFILM WAKO PURE CHEMICAL CORPORATION
    Labeler DUNS
    690598875
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-07
    Public Version
    5
    Public Version Date
    2020-10-26
    Public Version Status
    Update
    Public Device Record Key
    69f014f8-f2a2-4660-8e44-8b0ed4958225
    Distribution End Date
    2020-10-23

    Device Description

    In-Vitro Diagnostic Use

    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
    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
    OAU Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

    GMDN Terms

    Code Name
    47216 Des-gamma-carboxyprothrombin (DCP) IVD, reagent

    Identifiers

    Type ID
    Primary 00856626006120

    Premarket Submissions

    Submission Number Supplement Number
    K100464 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 10 Degrees Celsius