360Dx

FDA Clears Tests from Roche, Siemens Healthineers, Beckman Coulter, Others in February

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 ...

What’s the Point of PCR Tests Anymore?

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 ...
ABC7 San Francisco

FDA authorizes first breath test to detect COVID-19

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 ...
Business Wire

Visby Engages Quest and Labcorp to Broaden Consumer Access to First At-Home, FDA-Authorized PCR Test for STIs

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 ...
6abc News

FDA authorizes 1st COVID-19 antigen test, which produces results within minutes

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 ...
Business Wire

QuidelOrtho Receives FDA 510(k) Clearance for Its QuickVue® COVID-19 Test

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 ...