BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    QUANTA Lite® H.pylori IgG ELISA

    DI: 08426950593256 · Model: 708715 · 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 Lite® H.pylori IgG ELISA
    Primary DI
    08426950593256
    Version / Model
    708715
    Company Name
    INOVA DIAGNOSTICS, INC.
    Labeler DUNS
    188354831
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-31
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    4c3374e7-82e7-4a2c-ae18-1ca6c5cf9096

    Device Description

    1. 1x H. pylori IgG ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted H. pylori IgG ELISA Low Positive 4. 1x 1.2mL prediluted H. pylori IgG ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

    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
    LYR Helicobacter Pylori

    GMDN Terms

    Code Name
    51008 Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 08426950593256

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K982790 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius