FDA clears GenBody's COVID-19 test for asymptomatic people

LabPulse.com staff writers
Dec 8, 2021
2021 12 10 00 25 0789 Gen Body Test 400

The U.S. Food and Drug Administration (FDA) has provided clearance for GenBody America's COVID-19 antigen test kit to be used in asymptomatic patients.

Specifically, GenBody's COVID-19 antigen test kits can now be used for individuals without symptoms or other epidemiological reasons to suspect COVID-19 "when tested twice over two or three days, with at least 24 hours and no more than 48 hours between tests," the company stated in a release.

GenBody received an amendment to its original emergency use authorization from the FDA for the company's visually readable COVID-19 antigen test kit for use with anterior nasal swabs.

The GenBody America COVID-19 antigen test kit. Image courtesy of GenBody.The GenBody America COVID-19 antigen test kit. Image courtesy of GenBody.
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