The system is intended for use in urgent care clinics, primary care settings, physician office laboratories, and pharmacies.

NEW YORK – Lex Diagnostics said on Monday that it has obtained 510 (k) clearance and CLIA waiver from the US Food and Drug Administration for its Velo point-of-care molecular diagnostic system and an ...

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 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 ...

Used with the cobas ® 5800, 6800 and 8800 systems, cobas Respiratory 4-flex simultaneously detects and differentiates the four most common respiratory viruses, helping to ensure confidence in ...

The FDA has cleared a multiplex polymerase chain reaction test designed to detect 11 clinically relevant gastrointestinal pathogens from a single stool sample.The Xpert GI Panel (Cepheid) can identify ...

SALT LAKE CITY, Nov. 18, 2025 /PRNewswire/ --Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of ...

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 ...

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 ...