BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Group B Strep Assay

    DI: B178GBGBS100 · Model: GBGBS-10 · GREAT BASIN SCIENTIFIC, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Group B Strep Assay
    Primary DI
    B178GBGBS100
    Version / Model
    GBGBS-10
    Catalog Number
    GBGBS-10
    Company Name
    GREAT BASIN SCIENTIFIC, INC.
    Labeler DUNS
    827115259
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    11703581-5ef4-4b63-adf1-78b8b914c66c

    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
    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
    OOI Real Time Nucleic Acid Amplification System
    NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

    GMDN Terms

    Code Name
    51753 Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary B178GBGBS100
    Package B178GBGBS102

    Customer Contacts

    Phone
    (888) 333-9763
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius