Cepheid
Thermo Fisher Scientific, BioMérieux, Cepheid Gain 510(k) Clearances in October
The US Food and Drug Administration granted clearances for blood chemistry tests, antimicrobial susceptibility tests, and tests for current or prior infections.
Abbott, Siemens Healthineers, Beckman Coulter, Roche, Others Gain FDA Clearances in September
The agency granted marketing clearances for hematology and immunoassay analyzers along with infectious disease tests and assays used to guide cancer treatment.
Top Five Articles on 360Dx Last Week: Dx Companies' Plans for POC Testing; IVDR Rollout; More
Last week, readers were most interested in a story about the hurdles faced by companies bringing routine testing at the point of care.
Danaher Agrees to Provide Cepheid Tuberculosis Test to Global Fund at Cost
The tuberculosis test cartridges will be offered at $7.97 each to the Global Fund and less-developed countries eligible for Cepheid's Global Access Program.
Abbott, Beckman Coulter, Thermo Fisher Scientific, Others Gain FDA Clearances in August
The clearances granted in August include hematology equipment, COVID-19 tests, a lupus test, and reagent packs to aid management of cancer patients.