BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Anti-SARS-CoV-2 IgG

    DI: 00845533002851 · Model: SM9Z7901G · ZEUS SCIENTIFIC, INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Anti-SARS-CoV-2 IgG
    Primary DI
    00845533002851
    Version / Model
    SM9Z7901G
    Catalog Number
    SM9Z7901G
    Company Name
    ZEUS SCIENTIFIC, INC.
    Labeler DUNS
    080953946
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-04-01
    Public Version
    1
    Public Version Date
    2026-04-09
    Public Version Status
    New
    Public Device Record Key
    127b465c-a6f6-4625-95c0-c4c38af41bfb

    Device Description

    Anti-SARS-CoV-2 IgG is an ELISA-based test system intended for the qualitative detection of IgG antibodies to the SARS-CoV-2 virus in human serum and plasma (dipotassium EDTA, lithium heparin and sodium citrate) run manually or using the Dynex AGILITY, Dynex DSX or Dynex DS2 automated ELISA Systems. The Anti-SARS-CoV-2 IgG is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Anti-SARS-CoV-2 IgG should not be used to diagnose or exclude acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform moderate (automated method) or high (manual and automated method) complexity tests.

    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

    GMDN Terms

    Code Name
    64825 SARS-CoV-2 antigen IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00845533002851