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    FDA UDI In Commercial Distribution 🇺🇸 United States

    HemosIL AcuStar HIT-IgG (PF4-H)

    DI: 08426951126545 · Model: 0009800127 · INSTRUMENTATION LABORATORY COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    HemosIL AcuStar HIT-IgG (PF4-H)
    Primary DI
    08426951126545
    Version / Model
    0009800127
    Catalog Number
    00009800127
    Company Name
    INSTRUMENTATION LABORATORY COMPANY
    Labeler DUNS
    557223252
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-07-12
    Public Version
    3
    Public Version Date
    2021-07-13
    Public Version Status
    Update
    Public Device Record Key
    f15d49df-94ef-47d5-a5b1-07ff103d6f40

    Device Description

    1. HIT- IgG(PF4-H)Cartridges for 25 determinations (Cat No 0009800128) 2. HIT-IgG (PF4-H) Calibaratior 1 (Cat No 0009800129) 3. HIT-IgG (PF4-H) Calibaratior 2 (Cat No 0009800130)

    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
    LCO PLATELET FACTOR 4 RADIOIMMUNOASSAY

    GMDN Terms

    Code Name
    56095 Platelet factor 4 IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 08426951126545

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K170854 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours