BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IDG/Sanzay

    DI: 00850053916199 · Model: 1 · IDG/SANZAY Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IDG/Sanzay
    Primary DI
    00850053916199
    Version / Model
    1
    Catalog Number
    HC201
    Company Name
    IDG/SANZAY Corporation
    Labeler DUNS
    948875013
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-01-12
    Public Version
    1
    Public Version Date
    2024-01-22
    Public Version Status
    New
    Public Device Record Key
    f66d24df-6d63-492b-8407-b8e38d00a895

    Device Description

    The IDG APTT-EA reagent is an in vitro diagnostic assay intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    GFO Activated Partial Thromboplastin

    GMDN Terms

    Code Name
    55982 Activated partial thromboplastin time (APTT) IVD, reagent

    Identifiers

    Type ID
    Primary 00850053916199

    Premarket Submissions

    Submission Number Supplement Number
    K022021 000