QuidelOrtho Corporation QDEL recently announced that it has been granted a CLIA Waiver by the FDA, which applies to its new Sofia 2 SARS Antigen+ FIA (fluorescent immunoassay). The Sofia 2 SARS ...
Nuclein’s DASH SARS-CoV-2 & Flu A/B Test, which is designed for use with the DASH Rapid PCR System, has gained the US Food and Drug Administration (FDA) 510(k) clearance, as well as a Clinical ...
LOS ANGELES, Jan. 7, 2025 /PRNewswire/ -- CovarsaDx ®, a prominent Clinical Research Organization (CRO) renowned for its in vitro diagnostics (IVDs) and medical device expertise, announced today that ...
This achievement marks the beginning of a new era for IgE testing by delivering rapid, actionable results for allergists and immunologists.” — Moufeed Kaddoura ...
MEDFORD, N.Y., Feb. 24, 2023 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced receipt of a ...
SAN JOSE, Calif., Feb. 26, 2025 /PRNewswire/ -- Visby Medical ™ announced today that it has received 510(k) clearance and was granted a CLIA waiver from the U.S. Food and Drug Administration (FDA) for ...
Successful outcome will broaden market in US for FebriDx, which differentiates between non-bacterial and bacterial acute respiratory infections Developed by Lumos Diagnostics (ASX:LDX), FebriDx is a ...
Lumos starts FebriDx CLIA-waiver ... differentiates between non-bacterial and bacterial acute respiratory infections Special Report: Lumos Diagnostics has kicked off a key paediatric study in the US ...
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