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 ...
SAN DIEGO, CA - June 24, 2025 (NEWMEDIAWIRE) - Axim Biotechnologies, Inc. (OTCQB: AXIM), a leading developer of rapid diagnostic testing for ocular and systemic conditions, today announced that it has ...
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 ...
Roche’s cobas liat Bordetella test earns FDA clearance, delivering accurate whooping cough results in 15 minutes.
Detection of hepatitis C virus (HCV) in about an hour SUNNYVALE, Calif., June 27, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA De Novo marketing authorization and Clinical ...
HAUPPAUGE, N.Y., Nov. 28, 2022 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced the submission to the U ...
SANTA ANA, Calif., Sept. 15, 2025 /PRNewswire/ -- Today, Autonomous Medical Devices Incorporated (AMDI) announced its submission to the US Food and Drug Administration (FDA) of a dual 510(k) and CLIA ...
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, ...
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