510(k)
Zymo Research Gets 510(k) Clearance for Saliva Collection Kit for COVID-19 Testing
The kit is now cleared as a Class II medical device for microbial nucleic acid storage and stabilization, according to Zymo Research.
BioMérieux Submits Dual FDA Marketing, CLIA Waiver Application for Respiratory, Sore Throat Panel
The French diagnostics maker is seeking both 510(k) clearance and a CLIA waiver for the multiplex PCR test, which can be used at the point of care.
T2 Biosystems Gets FDA 510(k) Clearance for Biothreat Panel
The clearance allows the firm to immediately begin marketing an assay that simultaneously detects six biothreat pathogens directly from blood.
GenInCode Files FDA 510(k) Submission For Polygenic Cardiovascular Disease Risk Test
The test recently received a CPT PLA code and is currently offered through GenInCode's laboratory in Irvine, California.
BD Gains FDA Clearance for Combination COVID-19, Flu, RSV Molecular Test
The RT-PCR-based BD Respiratory Viral Panel for BD Max received a CE mark in 2022 and FDA Emergency Use Authorization earlier this year.