510(k)
Diasorin Nabs FDA 510(k) Clearance for Gram-Negative Bloodstream Infection Panel
The firm's Liaison Plex Gram-Negative Blood Culture Assay is used for the identification of 19 Gram-negative bacteria and eight resistance genes.
Visby Medical Gains FDA 510(k) Clearance, CLIA Waiver for POC Respiratory Panel
The Visby Medical Respiratory Health Test is a disposable handheld RT-PCR-based assay for the detection and differentiation of SARS-CoV-2 and flu A/B.
Co-Diagnostics Withdraws FDA COVID Test Submission, Plans New Version of Test
The company now intends to submit an enhanced version of its COVID-19 test for 510(k) clearance.
FDA Clears BioMérieux Gastrointestinal Panel
The panel detects 11 bacteria, viruses, and parasites that cause diarrheal disease with a turnaround time of approximately one hour.
Roche Lipoprotein (a) Test Receives FDA 510(k) Clearance
The test, which is intended for assessing cardiovascular risk, is the first lipoprotein (a), or Lp(a), test measured in nanomoles per liter to receive FDA clearance.
Jan 21, 2025