February 2019—Mesa Biotech has received 510(k) clearance and CLIA waiver from the FDA for its Accula RSV test, cleared for diagnosing children and adults.
The Accula RSV test is the second molecular POC diagnostic on the Accula platform to receive FDA clearance and CLIA waiver, following the company’s Flu A/Flu B test, cleared earlier in 2018. The Accula RSV test is indicated for use with nasal swab collection.
The RSV test, along with the flu A/B test, is marketed by Sekisui Diagnostics under the Silaris brand.
Mesa Biotech, 858-800-4929