Medically reviewed by Jordana Haber Hazan, MD Key Takeaways PCR tests are very accurate and can find the virus even in people without symptoms.Rapid tests can be done at home and show results in ...
“The GS™ COVID-19 RT-PCR KIT is a much-needed addition to the tool set that communities across the country are using to respond to the COVID-19 health emergency,” stated Joan Koerber-Walker, President ...
The system is intended for use in urgent care clinics, primary care settings, physician office laboratories, and pharmacies.
EVANSTON, Ill.--(BUSINESS WIRE)--Minute Molecular Diagnostics today announced that the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for its rapid DASH ...
The Company's Emergency Use Authorization submission is for the new Co-Dx PCR Pro instrument and COVID-19 test kit, designed for point-of-care and at-home. The menu of tests in development for the ...
LEX Diagnostics, a Cambridgeshire-based innovator in molecular diagnostics, has received U.S. Food and Drug Administration (FDA) 510(k) clearance and CLIA waived status for a platform that could ...
The Company expects that the application for OTC clearance will shortly be followed by pursuit of POC clearance, with other tests in the pipeline to meet the needs of a global market SALT LAKE CITY, ...
The FDA has cleared its first completely at-home sexual health test for women, available over-the-counter to screen for chlamydia, gonorrhea and trichomoniasis. The single-use kit from Visby Medical ...