BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HemosIL AcuStar D-Dimer

    DI: 08426950496946 · Model: 0009802000 · INSTRUMENTATION LABORATORY COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HemosIL AcuStar D-Dimer
    Primary DI
    08426950496946
    Version / Model
    0009802000
    Catalog Number
    0009802000
    Company Name
    INSTRUMENTATION LABORATORY COMPANY
    Labeler DUNS
    557223252
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    7
    Public Version Date
    2021-07-14
    Public Version Status
    Update
    Public Device Record Key
    78c7189b-c255-46e2-a6c9-34db1dbe00aa

    Device Description

    HemosIL AcuStar D-Dimer

    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
    DAP FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL

    GMDN Terms

    Code Name
    47346 D-dimer IVD, kit, agglutination

    Identifiers

    Type ID
    Primary 08426950496946

    Customer Contacts

    Phone
    1-800-678-0710
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K083518 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius