The CLIA-waived CitoCBC® expands patient access to quick CBC results in physician offices, pharmacies, and home care, enabling data-driven diagnostics. CBC is one of the most commonly requested lab ...
MEDFORD, N.Y., Feb. 24, 2023 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced receipt of a Clinical ...
Lumos Diagnostics has kicked off a key paediatric study in the US for its FebriDx rapid diagnostic test, marking a ...
On Dec. 28, 2023, the Centers for Medicare and Medicaid Services (CMS) released a final rule that updates Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarifies CLIA regulations.
Palo Alto-based novel blood test company Theranos was granted a waiver from the FDA allowing the company to offer its first FDA-cleared blood test, its herpes simplex 1 virus IgG (HSV IgG) test, ...
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 ...
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 ...
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 ...
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