510(k)
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.
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.
Gold Standard Diagnostics Nabs FDA Clearance for Lyme Disease Test
The test can be used in conjunction with other FDA-cleared Lyme enzyme immunoassays developed by GSD as part of a CDC-recommended modified two-tiered testing algorithm.
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.
DiaSorin, Roche, Inova Diagnostics Receive FDA 510(k) Clearances in February
DiaSorin got the green light for its Liaison Anti-HAV chemiluminescent immunoassay to detect total antibodies to the hepatitis A virus.