BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    illumigene Group A Streptococcus External Control Kit

    DI: 00840733101328 · Model: 279910 · MERIDIAN BIOSCIENCE, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    illumigene Group A Streptococcus External Control Kit
    Primary DI
    00840733101328
    Version / Model
    279910
    Catalog Number
    279910
    Company Name
    MERIDIAN BIOSCIENCE, INC.
    Labeler DUNS
    092815364
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    4
    Public Version Date
    2020-07-16
    Public Version Status
    Update
    Public Device Record Key
    5010624b-d0c5-466e-a9a1-a0ccd09bf11b
    Distribution End Date
    2019-12-20

    Device Description

    The illumigene Group A Streptococcus (Group A Strep) External Control Kit contains Positive Reagent for use with the illumigene Group A Streptococcus DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the illumigene Sample Preparation Apparatus II/Negative Control III reagent provided with the Group A Strep Kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program.

    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
    OYZ Group A Streptococcus Nucleic Acid Amplification Assay System

    GMDN Terms

    Code Name
    51716 Beta-haemolytic Group A Streptococcus nucleic acid IVD, control

    Identifiers

    Type ID
    Primary 00840733101328

    Customer Contacts

    Phone
    513-271-3700
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K122019 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius