Medical Device Network on MSN14d
FDA grants 510(k) clearance for Visby’s respiratory infections detection test
The 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 ...
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Roche’s STI assay panels gain FDA 510(k) clearance and CLIA waiver
Roche has received 510(k) clearance with a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver from the US Food and Drug Administration (FDA) for its cobas liat sexually transmitted ...
Pharmabiz1mon
US FDA grants 510(k) clearance and CLIA waiver to Roche’s cobas liat sexually transmitted infection multiplex assay panels
Roche announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas liat sexually transmitted ...
Yahoo Finance15d
Visby Medical™ Receives FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test
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 ...
KELOLAND News16d
CytoChip Receives FDA Clearance and First CLIA Waiver for a Cartridge-Based Complete Blood Count Test
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 ...
Mena FN16d
Cytochip Receives FDA Clearance And First CLIA Waiver For A Cartridge-Based Complete Blood Count Test
(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 ...