Phadia
FDA Clears Thermo Fisher Scientific Tests to Help Diagnose Systemic Sclerosis, Lupus
The Thermo Scientific EliA RNA Pol III assay detects antibodies to RNA polymerase III, while the EliA Rib-P test looks for monospecific ribosomal P antibodies.
Thermo Fisher Scientific Unit Phadia Gets FDA EUA for Coronavirus Antibody Test
The fluoro-enzyme immunoassay is designed for the qualitative and semi-quantitative detection of immunoglobulin G against SARS-CoV-2.
Siemens Healthineers, Hologic, DiaSorin, BioMérieux, Others Get FDA Clearances in May
Hologic received clearance for a change to a probe reagent in the Aptima Combo 2 assay to detect variants of Chlamydia trachomatis that have emerged recently.
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.
Siemens Healthineers, Roche Diagnostics, BioMérieux, Cepheid, and Others Receive FDA Clearances in July
Siemens Healthineers received FDA clearances for several assays, including separate allowances for tests using hemoglobin A1c, troponin I, and procalcitonin biomarkers.