SOURCE: General Atomics

General Atomics

July 07, 2014 15:22 ET

FDA Grants Diazyme 510(k) Clearance to Market Its Ferritin Assay for Clinical Chemistry Analyzers

SAN DIEGO, CA--(Marketwired - Jul 7, 2014) - Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its Ferritin Assay. In line with current clinical needs, Diazyme's Ferritin Latex-Enhanced Immunoturbidimetric Assay can be utilized to measure levels of ferritin in serum and plasma samples as part of a work up of patients with iron deficiency issues. Utilization of this technology allows for highly reliable and precise test results, with minimal sample volumes. The Diazyme Ferritin Assay is both fast and flexible with complete test results in minutes. Furthermore, the assay is designed to work on most high throughput clinical chemistry analyzers, allowing users faster results and improved laboratory workflow.

"Diazyme's Ferritin Assay provides an effective test method for laboratories of virtually all sizes," said Dr. Chong Yuan, Managing Director of Diazyme Laboratories. "The sensitivity of the assay allows ferritin levels to be measured very efficiently and effectively. This high-throughput liquid stable assay provides precise test results, is user friendly, cost effective and has excellent correlation to the existing commercial methods."

Diazyme Laboratories is a division of General Atomics headquartered in La Jolla, California. Diazyme uses its enzyme platform technologies to develop innovative assays for clinical and research uses with reduced costs and improved performance. Products include diagnostic blood tests for cardiac markers, diabetes, nutritional assessment, liver disease, renal disease and electrolytes. Information regarding Diazyme's enzyme technology and related products can be found on its website at www.diazyme.com.

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