BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HemosIL CL HIT-IgG (PF4-H)

    DI: 00195226001204 · Model: 0029706200 · 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 CL HIT-IgG (PF4-H)
    Primary DI
    00195226001204
    Version / Model
    0029706200
    Catalog Number
    00029706200
    Company Name
    INSTRUMENTATION LABORATORY COMPANY
    Labeler DUNS
    557223252
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-30
    Public Version
    1
    Public Version Date
    2025-11-07
    Public Version Status
    New
    Public Device Record Key
    0dc84a0c-f8fa-4c1d-9dde-66399379367f

    Device Description

    HemosIL CL HIT-IgG (PF4-H) CL HIT-IgG(PF4-H) Cartridge (Cat. No. 0029706210): 1 CL HIT-IgG(PF4-H) Calibrator 1 (Cat. No. 0029706220): 1 x 1.2 mL CL HIT-IgG(PF4-H) Calibrator 2 (Cat. No. 0029706230): 1 x 1.2 mL

    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 00195226001204

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K243374 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius