BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    QUANTA Flash® B2GP1 IgG Reagents

    DI: 08426951289264 · Model: 701245 · INOVA DIAGNOSTICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    QUANTA Flash® B2GP1 IgG Reagents
    Primary DI
    08426951289264
    Version / Model
    701245
    Company Name
    INOVA DIAGNOSTICS, INC.
    Labeler DUNS
    188354831
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-09-27
    Public Version
    2
    Public Version Date
    2022-10-10
    Public Version Status
    Update
    Public Device Record Key
    ca528ae4-20bb-45a8-bc59-d19ee86edebc

    Device Description

    1 QUANTA Flash B2GP1 IgG Reagent Cartridge 1 QUANTA Flash B2GP1 IgG Calibrator 1 1 QUANTA Flash B2GP1 IgG Calibrator 2

    Device Characteristics

    Single Use
    Yes
    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
    MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

    GMDN Terms

    Code Name
    53929 Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 08426951289264

    Customer Contacts

    Phone
    1-800-545-9495
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K091556 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius