BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Revogene® Strep A

    DI: 00628055344179 · Model: 410400 · Meridian Bioscience Canada Inc
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Revogene® Strep A
    Primary DI
    00628055344179
    Version / Model
    410400
    Catalog Number
    410400
    Company Name
    Meridian Bioscience Canada Inc
    Labeler DUNS
    204006360
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-21
    Public Version
    3
    Public Version Date
    2021-11-08
    Public Version Status
    Update
    Public Device Record Key
    46f8fac7-4683-4201-a413-de898384c8a3
    Distribution End Date
    2021-09-30

    Device Description

    The Revogene® 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 Revogene 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
    PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
    OOI Real Time 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 00628055344179

    Customer Contacts

    Phone
    1-800-343-3858
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 25 Degrees Celsius