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Beckman Coulter's DxC 500 AU Clinical Chemistry Analyzer and Siemens Healthineers' Atellica CI Analyzer are among the 510(k) clearances issued in July.
The company's point-of-care revenues dropped 73 percent, while molecular lab sales declined 50 percent.
Findings from technical validations and in-service valuations reviewed by the Technical Validation Group.
The FDA released a letter on Friday warning clinical laboratory and point-of-care staff, as well as healthcare providers, that false positive results for Roche's test for coronavirus and influenza A/B may occur.