BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Elecsys Anti-SARS-CoV 2

    DI: 07613336179444 · Model: 09203079190 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Elecsys Anti-SARS-CoV 2
    Primary DI
    07613336179444
    Version / Model
    09203079190
    Catalog Number
    09203079190
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-07-22
    Public Version
    2
    Public Version Date
    2026-02-23
    Public Version Status
    Update
    Public Device Record Key
    beacbf0a-e07e-4924-af11-df74bba8bf57

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    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
    QVP SARS-CoV-2 serology test

    GMDN Terms

    Code Name
    64760 SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 07613336179444

    Premarket Submissions

    Submission Number Supplement Number
    K250768 000
    K253839 000