Axis-Shield
BioMérieux, Siemens Healthineers, Roche Diagnostics, Others Get FDA Clearances in August
Roche Diagnostics got the nod for its Elecsys Anti-HAV II test for the detection of total antibodies — IgG and IgM — to the hepatitis A virus.
BioMérieux, DiaSorin, GenMark, and Others Receive FDA Clearances in December
GenMark got clearance for an assay to detect fungal pathogens from blood cultures of patients with suspected bloodstream infections, and it received clearance for a bacterial assay.