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 ...
KELOLAND News17d
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 FN1mon
Roche Receives FDA Clearance With CLIA Waiver For Cobas® Liat Molecular Tests To Diagnose Sexually Transmitted Infections At The Point Of Care
C. diff has been cleared by the FDA for use by authorised laboratories under CLIA to perform moderate complexity testing. Founded in 1896 in Basel, Switzerland, as one of the first industrial ...
Mena FN17d
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 ...