BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Heparin/PF4 Antibody Serum Panel

    DI: 00708872000004 · Model: 4036027 · AKERS BIOSCIENCES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

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    Basic Information

    Brand Name
    Heparin/PF4 Antibody Serum Panel
    Primary DI
    00708872000004
    Version / Model
    4036027
    Catalog Number
    4036027
    Company Name
    AKERS BIOSCIENCES, INC.
    Labeler DUNS
    611245549
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2018-03-05
    Public Version
    2
    Public Version Date
    2018-07-06
    Public Version Status
    New
    Public Device Record Key
    8aba698e-c39e-417c-a287-24b219de73fa

    Device Description

    The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and evaluate precision and accuracy of the (qualitative) PIFA® Heparin/PF4 Rapid Assay. Included are both confirmed positive and negative control panel members.

    Device Characteristics

    Single Use
    Yes
    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
    GGN Plasma, Coagulation Control

    GMDN Terms

    Code Name
    60534 Platelet factor 4-heparin complex antibody IVD, control

    Identifiers

    Type ID
    Primary 00708872000004
    Unit of Use 01708872000004

    Customer Contacts

    Phone
    8568488698
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K052697 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -70 – -70 Degrees Celsius