Beckman Coulter
Qiagen, Danaher, Thermo Fisher Scientific, Others Gain 510(k) Clearances in October
The US Food and Drug Administration granted clearances for various tests for infectious diseases, coagulation disorders, and drug susceptibility.
Beckman Coulter to Distribute BioPorto Acute Kidney Injury Tests
Beckman Coulter will distribute the neutrophil gelatinase-associated lipocalin tests for use on Beckman's portfolio of DxC and AU clinical chemistry analyzers.
Beckman Coulter, T2 Biosystems, Others Gain 510(k) Clearances in September
The US Food and Drug Administration granted marketing clearances for multiple infectious disease tests and a blood culture sample preparation system, among other devices.
Abbott, QuidelOrtho, Werfen, Others Gain 510(k) Clearances in August
The US Food and Drug Administration granted marketing clearances for immunoassays for a variety of infectious diseases including syphilis, Lyme, and COVID-19.
FDA Grants 510(k) Clearances to Beckman Coulter, Siemens Healthineers, Hologic, Others in July
The US FDA granted clearance to hematology analyzers and assays for chronic, emergency, and infectious disease uses, among other tests and instruments.