Tag Archives: Mesa Biotech

January 2021—Mesa Biotech received 510(k) clearance and CLIA waiver from the FDA for its Accula Strep A test. The strep A cassette, for the molecular detection of group A Streptococcus bacterial nucleic acid, is cleared for diagnosing children and adults and provides results in 30 minutes at the point of care.

September 2019—Mesa Biotech launched its respiratory syncytial virus test, the company’s second point-of-care test on its polymerase chain reaction testing platform, the Accula System, at the AACC annual scientific meeting. The Accula Flu A/Flu B test received FDA clearance in 2018. Both tests are indicated for use with nasal swab collection.

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.

April 2018—Mesa Biotech announced its Accula Flu A/Flu B test is FDA 510(k) cleared and CLIA waived. It is the company’s first flu A/flu B test cassette available in the U.S. The PCR test provides results in approximately 30 minutes. It will be marketed by Sekisui Diagnostics under the Silaris brand.