360Dx2d
With FDA Clearance for POC Complete Blood Count Test, CytoChip Prepares for US Commercialization
A study published in November in the American Journal of Clinical Pathology that Emerson co-authored validated the analyzer against the Sysmex XN Automated Hematology System and found that CytoChip's ...
GlobalData on MSN15d
FDA grants 510(k) clearance for Visby’s respiratory infections detection test
The FDA has granted 510(k) clearance for Visby Medical’s polymerase chain reaction (PCR) test to detect respiratory ...
KELOLAND News17d
CytoChip Receives FDA Clearance and First CLIA Waiver for a Cartridge-Based Complete Blood Count Test
A CLIA-waived solution like CitoCBC ® is crucial for delivering personalized CBC testing routinely in primary care, enabling proactive patient management. CitoCBC ® is engineered for both ease ...
Yahoo Finance16d
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 ...
Mena FN1mon
Roche Receives FDA Clearance With CLIA Waiver For Cobas® Liat Molecular Tests To Diagnose Sexually Transmitted Infections At The Point Of Care
The cobas liat assays are CLIA waived*, enabling healthcare professionals to perform molecular testing in a variety of near-patient settings with speed, reliability and minimal training.
Morningstar23d
Amplified Sciences earns CLIA certification for its first test to assess pancreatic cancer risk
Morningstar brands and products Company Portfolio ...
abc2716d
Avance Biosciences™ Registers with CLIA, Expanding Clinical Trial Testing Capabilities
This registration allows Avance Biosciences to operate under its assigned CLIA number and offer high-complexity laboratory testing to support clinical trials, regulatory submissions, and the ...