Now, you’d likely use an at-home test, which spits out results in just 15 minutes. It’s easier, faster, and reliable, even against the latest variants. Though they’re not perfect, at-home tests will ...
In February, the US Food and Drug Administration granted 510(k) clearance to a dozen in vitro diagnostic tests encompassing molecular, immunoassay, clinical chemistry, and ion selective electrode ...
WASHINGTON -- The US Food and Drug Administration has granted emergency use authorization to the first Covid-19 test that spots chemical compounds associated with the coronavirus in breath, the agency ...
SAN JOSE, Calif.--(BUSINESS WIRE)--Today, Visby Medical announced two new relationships that will expand national access to the Visby Women’s Sexual Health Test, the first, at-home, FDA-authorized PCR ...
The Food and Drug Administration has authorized emergency use of the first antigen coronavirus test, which produces results within minutes and is relatively cheap to make, according to the agency. The ...
July 6, 2012 — The US Food and Drug Administration (FDA) has approved the therascreen® KRAS RGQ PCR Kit to be sold as a companion diagnostic test for cetuximab (Erbitux). In addition, the FDA has ...
SAN DIEGO--(BUSINESS WIRE)--QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho" or the “Company”) has received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its QuickVue COVID-19 ...
The FINANCIAL — Roche on September 22 announced that the U.S. Food and Drug Administration (FDA) has granted CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas Influenza A/B test ...
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