Sep 29, 2006 | Laboratory News, Laboratory Pathology
On September 18, Magellan Biosciences announced that the FDA had granted a CLIA waiver for its new LeadCare® II blood-lead testing system, developed and marketed by the company’s subsidiary, ESA Biosciences. This device is now cleared to be used in non-laboratory settings, such as schools and mobile lead testing vans. The device is a key element of Magellan’s strategy to expand its offerings into the global point-of-care clinical-diagnostic market. Any CLIA waver for a test is...