BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Alere™ i Strep A

    DI: 10811877010859 · Model: 733-000 · Alere Scarborough, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Alere™ i Strep A
    Primary DI
    10811877010859
    Version / Model
    733-000
    Company Name
    Alere Scarborough, Inc.
    Labeler DUNS
    154148498
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-03
    Public Version
    3
    Public Version Date
    2023-09-12
    Public Version Status
    Update
    Public Device Record Key
    db1a60ae-95aa-4756-826d-d97f7b1d161f
    Distribution End Date
    2019-04-25

    Device Description

    A rapid, automated, molecular test for the qualitative detection of Streptococcus pyogenes Group A bacterial nucleic acid in throat swab specimens.

    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
    No
    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 10811877010859