BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NeuMoDx SARS-CoV-2 Test Strip

    DI: 10814278021264 · Model: 300800 · Neumodx Molecular, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

    Basic Information

    Brand Name
    NeuMoDx SARS-CoV-2 Test Strip
    Primary DI
    10814278021264
    Version / Model
    300800
    Catalog Number
    300800
    Company Name
    Neumodx Molecular, Inc.
    Labeler DUNS
    078667309
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2020-04-23
    Public Version
    1
    Public Version Date
    2020-05-01
    Public Version Status
    New
    Public Device Record Key
    42ed7a9d-2937-4d32-b083-e0e4c5bd4b71

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Serial Number
    Yes
    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
    Unit of Use 00814278021267
    Primary 10814278021264