510(k)
FDA Clears Zymo Research Coronavirus Sample Collection Device
Zymo Research previously received CE-IVD marking for the collection device, which enables the transport and storage of SARS-CoV-2 RNA at ambient temperatures.
Luminex Nabs $11.3M From BARDA to Develop Test for SARS-CoV-2, Flu, RSV
The firm said it intends to apply to obtain FDA Emergency Use Authorization and 510(k) clearance for a panel that detects respiratory targets in a single test.
Roche Receives FDA Clearance for Cobas BKV Test for Use With Urine Samples
The test was previously cleared by the FDA for use with ethylenediaminetetraacetic acid plasma samples to manage BK virus in transplant patients.
Mesa Biotech Receives 510(k) Clearance, CLIA Waiver for Strep A Molecular Point-of-Care Test
The firm said its test fits in the palm of a hand and delivers results in 30 minutes by detecting bacterial nucleic acid in throat, nasal, or nasopharyngeal swabs.
OpGen Provides Additional Info to FDA on Antimicrobial Resistance Gene Panel
The company first submitted for 510(k) clearance last year and has received two additional information requests from the agency.