BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ID NOW™ COVID-19

    DI: 10811877011269 · Model: 190-000 · Alere Scarborough, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ID NOW™ COVID-19
    Primary DI
    10811877011269
    Version / Model
    190-000
    Company Name
    Alere Scarborough, Inc.
    Labeler DUNS
    154148498
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-30
    Public Version
    2
    Public Version Date
    2023-09-12
    Public Version Status
    Update
    Public Device Record Key
    84d30b14-4efd-4a2e-bc18-9390d79ffa1e
    Distribution End Date
    2022-12-22

    Device Description

    A rapid, automated, molecular test for the qualitative detection of COVID-19 viral nucleic acid in respiratory specimens.

    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
    QJR Reagents, 2019-Novel Coronavirus Nucleic Acid

    GMDN Terms

    Code Name
    64747 SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 10811877011269