Abaxis Receives CLIA Waived Status For 6 Additional Analytes By FDA

Nov 1, 2006 | Laboratory News, Laboratory Pathology

On Wednesday, October 18, Abaxis, Inc., a manufacturer of portable blood analysis systems, revealed that the FDA granted waived status under CLIA regulations for six additional analytes, when those analytes are used in conjuction with the Piccolo point-of-care analyzer for the medical market. The analytes include: Amylase, Gamma Glutamyltransferase, Total Bilirubin, and Total Protein. The company noted that including the six analytes, it now has a total of 12 analytes that have received the...

New Lead Test Technology Moves Diagnostic Testing Closer to Point of Care

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...
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