510(k)
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.
The molecular test is used to differentiate bacterial infections, viral infections, and noninfectious disease and to assess the risk that patients will develop severe illness.
Diasorin Submits Gram-Positive Bacteria Panel for FDA 510(k) Clearance
The Gram-positive blood culture assay is the firm's third panel for the detection and identification of bloodstream pathogens using the Liaison Plex instrument.
Diasorin Submits Gram-Negative Bacteria Panel for FDA 510(k) Clearance
The firm's Gram-negative blood culture assay is used to identify bacterial pathogens and drug resistances, with results within two hours of a Gram stain.