The Visby Medical platform offers true PCR technology; PCR is the gold standard for testing Flu A, Flu B, and COVID-19. The Visby Medical Respiratory Health Test, which fits in the palm of your ...
(MENAFN- EIN Presswire) The CLIA-waived CitoCBC® expands patient access to quick CBC results in physician offices, pharmacies, and home care, enabling data-driven diagnostics. IRVINE, CA, UNITED ...
GlobalData on MSN14d
FDA grants 510(k) clearance for Visby’s respiratory infections detection testThe US Food and Drug Administration (FDA) has granted 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for Visby Medical’s polymerase chain reaction (PCR) test to detect ...
The FDA clearance with CLIA Waiver (510(k) number K240402 and CLIA Waiver CW240006) validates its accuracy and reliability, ensuring that even non-laboratory personnel can operate the system ...
Dynamic Biopsy non-invasively analyses dynamic biological processes within a specific organ or tissue to assess its health ...
Operator: Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the Daxor Corporation Conference ...
FDA requested additional information to supplement the application. Daxor elected to re-file this submission as a single ...
Aptitude Medical Systems, Inc. (Aptitude) today announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its next-gen molecular Metrix® ...
The company’s CLIA-certified lab in Irvine ... and a faculty member of the Purdue Institute for Cancer Research and the Purdue Institute for Drug Discovery. He said PanCystPro helps risk stratify ...
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