LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K251697

    Validate with FDA (Live)

    Device Name
    Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip
    Manufacturer
    Acon Laboratories, Inc.
    Date Cleared
    2025-11-26

    (177 days)

    Product Code
    GTY
    Regulation Number
    866.3740
    Type
    Dual Track
    Panel
    Microbiology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Flowflex® Plus Strep A Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Group A Streptococcus antigen from throat swab specimens from symptomatic patients. The test is used to aid in the diagnosis of Group A Streptococcal infection. All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.

    The Flowflex® Plus Strep A Rapid Test Strip is a rapid chromatographic immunoassay for the qualitative detection of Group A Streptococcus antigen from throat swab specimens from symptomatic patients. The test is used to aid in the diagnosis of Group A Streptococcal infection. All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.

    Device Description

    Not Found

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1