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FDA clearance

If the proposal is finalized, the tests will go through a less burdensome process to obtain marketing clearances.

The panel can detect and differentiate SARS-CoV-2 and 20 other pathogens known to cause serious respiratory disease from nasopharyngeal swabs in symptomatic patients.

The analyzer supports COVID-19 response efforts, where blood-gas testing plays a critical role in monitoring patients' respiratory distress, the firm said.

The analyzer and assay use immunofluorescent technology to detect H. pylori antigens in human stool and helps eliminate subjectivity.

The test is the third to receive EUA, following tests from the CDC and New York state, and it runs on Roche's Cobas 6800 and 8800 systems.

The at-home test is designed to measure the presence of PdG, a urine metabolite of the hormone progesterone, to help women confirm successful ovulation.

Abbott received five separate clearances associated with its i-Stat Chem8+ cartridge running on the company's iStat 1 system.

The agency said all tests for the virus must pass through its EUA process, but noted a test could be authorized under a single EUA for use in multiple labs.

The firm's AmplideX Fragile X Dx and Carrier Screen Kit is intended to help diagnose fragile X syndrome and assess parental risk of having a child with the syndrome.

DiaSorin got the nod for the Liaison Lyme Total Antibody Plus assay which uses chemiluminescence to detect lgG and IgM antibodies to Borrelia burgdorferi.

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