BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    GenePOC™ Strep A

    DI: 00628055344087 · Model: 133674 · GenePoc Inc
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GenePOC™ Strep A
    Primary DI
    00628055344087
    Version / Model
    133674
    Catalog Number
    133674
    Company Name
    GenePoc Inc
    Labeler DUNS
    202672846
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-04-30
    Public Version
    2
    Public Version Date
    2021-10-01
    Public Version Status
    Update
    Public Device Record Key
    f5d5927b-438d-433f-bb51-e30714dd1933
    Distribution End Date
    2021-09-30

    Device Description

    The GenePOC Strep A assay, performed on the revogene instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The GenePOC Strep A assay is intended for use as an aid in the diagnosis of Group A Streptococcus infection.

    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
    OOI Real Time Nucleic Acid Amplification System
    PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

    GMDN Terms

    Code Name
    51714 Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 00628055344087

    Customer Contacts

    Phone
    1-844-616-1544
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 25 Degrees Celsius