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The US Food and Drug Administration granted clearances for infectious disease tests, digital pathology software, and hematology analyzers, among other in vitro diagnostic technologies.
The rapid lateral flow assay from Lumos Diagnostics distinguishes bacterial and nonbacterial respiratory infections using a drop of blood.
The agency said that the test is unnecessary for the screening of whole blood and blood components that are screened with nucleic acid tests and core antigen tests.
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