BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    QUANTA Lite® ACA Screen III

    DI: 08426950454489 · Model: 708620 · INOVA DIAGNOSTICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    QUANTA Lite® ACA Screen III
    Primary DI
    08426950454489
    Version / Model
    708620
    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
    31ed8cb1-20f6-412b-9878-a903187664fc

    Device Description

    1. 1x Cardiolipin ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ACA Negative Control 3. 1x 1.2mL prediluted ACA III Decision Point 4. 1x 1.2mL prediluted ACA III Screen Control 5. 1x 50mL ACA III Sample Diluent 6. 1x 50mL ACA III PBS Concentrate, 20x concentrate 7. 1x 10mL HRP IgGAM Conjugate, (goat), anti-human IgGAM 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
    MID System, Test, Anticardiolipin Immunological

    GMDN Terms

    Code Name
    54870 Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 08426950454489

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K953291 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius