To maintain the quality of laboratory testing, CLIA requires that laboratories performing moderate or high-complexity testing enroll in an approved proficiency testing program for independent ...
Medical Device Network on MSN
Roche’s test for Bordetella infections gains FDA clearance
Roche’s point-of-care polymerase chain reaction (PCR) test for pertussis (whooping cough) and other Bordetella infections has ...
STONY BROOK, N.Y.--(BUSINESS WIRE)-- Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that ...
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 ...
A newly cleared point-of-care test will enable rapid identification of whooping cough, according to a press release from ...
There are two organizations that play a complementary role in ensuring regulatory compliance in laboratory diagnostics and the development of at-home diagnostics. The Food and Drug Administration (FDA ...
The onset of COVID-19 proved to be a real-time stress test of America’s clinical testing system. The experience exposed several flaws in the system that policymakers should address, specifically, ...
LetsGetChecked offers a range of multiple STI tests in collaboration with CLIA-certified laboratories. This test can identify the five most common STIs, making it a good option for those who want to ...
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