Simplexa Flu A/B & RSV Direct assay

Manufacturer

2 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Description
    In-vitro diagnostics - microbiological products
  • Manufacturer
  • Model / Serial
    Model Number   MOL2650 Lot Numbers: 24493, 24495, 24535, 24536.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) including states of: NY, MA, NJ, OH, CA, HI, CO, MN, FL, PA, IA, WI, AZ, TX, TN, IL, SD, MO, NM, AR, WV, MI and Internationally to: Sweden, Israel, Canada, and Slovenia. .
  • Product Description
    Simplexa Flu A/B & RSV Direct assay, Model MOL2650. || The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.
  • Manufacturer