CLIA stands for Clinical Laboratory Improvement Amendments. The CLIA of 1988 established certification requirements and more stringent quality standards for laboratory testing of human specimens.
The FDA cleared for commercial distribution a diagnostic panel that tests for multiple respiratory viral and bacterial infections on Feb. 3. The BioFire Spotfire Respiratory Panel is the first ...
FORT WORTH, Texas, July 21, 2021 /PRNewswire/ -- FDS Amplicare, a leading pharmacy technology provider, and its training partners, Don and Mike Klepser, both pharmacy professors and leading experts in ...
SAN DIEGO — TearLab Corporation did not gain approval from the U.S. Food and Drug Administration for its Clinical Laboratory Improvement Amendments certificate application, the company announced in a ...
BOSTON, March 30, 2021 /PRNewswire/ -- binx health, a population health technology company that provides convenient healthcare solutions, announced today that the US Food and Drug Administration (FDA) ...
Today, the U.S. Food and Drug Administration announced it is allowing the use of the Binx Health IO CT/NG Assay at point-of-care settings, such as in physician offices, community-based clinics, urgent ...
CLIA requires that US clinical laboratories obtain a certificate before accepting materials derived from the human body for laboratory tests, and laboratories that perform only tests that are "simple" ...
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