BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pointe Scientific, Inc. Rubella IgG

    DI: 00811727015174 · Model: T8003-96 · POINTE SCIENTIFIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Pointe Scientific, Inc. Rubella IgG
    Primary DI
    00811727015174
    Version / Model
    T8003-96
    Catalog Number
    T8003-96
    Company Name
    POINTE SCIENTIFIC, INC.
    Labeler DUNS
    045623154
    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
    14e9ac02-d109-4f7c-bab6-c89a3359cb20

    Device Description

    Pointe Scientific, Inc. Rubella IgG is for the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment of the patient's immunological response to rubella, and as a qualitative screening test to determine the immune status of individuals, including women of childbearing age. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests

    Device Characteristics

    Single Use
    No
    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
    LFX Enzyme Linked Immunoabsorbent Assay, Rubella

    GMDN Terms

    Code Name
    50265 Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00811727015174

    Customer Contacts

    Phone
    800-445-9853
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K961053 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius