Mesa Biotech’s Accula RSV Test Receives FDA’s 510(K) Clearance and CLIA Waiver for Respiratory Infections

Mesa Biotech’s Accula RSV Test Receives FDA’s 510(K) Clearance and CLIA Waiver for Respiratory Infections

Shots:

  • Accula RSV is second POC (point-of-care) test, to receive FDA’s 510(K) & CLIA Waiver and used additionally with nasal swab collection with disposable test cassettes
  • The Accula RSV (respiratory syncytial virus) test is performed for detection of respiratory tract infections like bronchiolitis & pneumonia in adults and children
  • In 2017, Sekisui Diagnostics collaborated with Mesa Biotech for commercialization of Accula RSV test as Silaris in the US and Canada

Click here to read full press release/ article | Ref: Mesa Biotech | Image: FDA News