FDA clearance
FDA Clears Sysmex Hematology Analyzer With Blood Bank Mode
The firm said that its XN Blood Bank mode provides accurate cell counts on products that are important to blood centers and blood banks.
FDA Approves Amgen's Lumakras for NSCLC Alongside Companion Tests From Guardant Health, Qiagen
The approval makes Lumakras the first inhibitor of KRAS, once considered "undruggable," to reach the market for KRAS-mutated NSCLC.
Immunodiagnostic Systems, Retractable Technologies, Immunalysis Receive FDA 510(k) Clearances in April
Immunalysis received 510(k) clearance for its Sefria PCP Oral Fluid Enzyme Immunoassay for the analysis of phenylcyclohexyl piperidine, or PCP, in human oral fluid.
FDA Grants EUA to Enzo Biochem Sample Collection Kit for COVID-19 Testing
The company said its Ampicollect kit is now available for sample collection as part of COVID-19 testing protocols in the US.
Thermo Fisher Scientific Gets FDA EUA for High-Throughput, Automated COVID-19 Test Kit
This modular system uses a high-throughput version of the company's Applied Biosystems TaqPath COVID-19 Combo Kit, which received an EUA in March 2020.
Sep 8, 2020
FDA Clears DiaSorin Test for Influenza, RSV
Sep 8, 2020