BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    QUANTA Flash RF IgM Reagents

    DI: 08426950845249 · Model: 701340 · 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 RF IgM Reagents
    Primary DI
    08426950845249
    Version / Model
    701340
    Company Name
    INOVA DIAGNOSTICS, INC.
    Labeler DUNS
    188354831
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-09-20
    Public Version
    1
    Public Version Date
    2019-09-30
    Public Version Status
    New
    Public Device Record Key
    7a388e60-7dd7-4165-9124-eb7f69fc977c

    Device Description

    1. QUANTA Flash RF IgM Reagent Cartridge contains the following reagents for 100 determinations: a. Rabbit pAb coated paramagnetic beads. b. Assay buffer - colored pink, containing proteing stabilizers and preservatives. c. Tracer IgM - Isoluminol labeled anti-human IgM antibody, containing buffer, protein stabilizers and preservatives.

    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
    DHR System, Test, Rheumatoid Factor

    GMDN Terms

    Code Name
    55110 Rheumatoid factor IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 08426950845249

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K190088 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius