FDA Grants Diazyme 510(k) Clearance to Market Its New EZ Vitamin D Assay for Clinical Chemistry Analyzers

Le par GlobeNewswire  |  0 commentaire(s)

SAN DIEGO, Jan. 22, 2018 (GLOBE NEWSWIRE) -- Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to market its EZVitamin D assay for Clinical Chemistry Analyzers. Diazyme's two ...

SAN DIEGO, Jan. 22, 2018 (GLOBE NEWSWIRE) -- Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to market its EZ Vitamin D assay for Clinical Chemistry Analyzers. Diazyme's two reagent EZ Vitamin D assay provides the only fully automated two reagent Vitamin D test for use on validated clinical chemistry analyzers.

"Diazyme's EZ Vitamin D assay is a universal fully automated Vitamin D test that is specifically designed for use on clinical chemistry analyzers.  This liquid stable, ready-to-use two reagent system measures total 25-hydroxy Vitamin D (25-OH Vitamin D2 + 25-OH Vitamin D3) levels. This assay enables clinical laboratories of almost any size to run Vitamin D test in house without the need for expensive specialized instrumentation. With no sample pre-treatment or pre-dilution steps required, this high-throughput liquid stable assay provides precise test results, is user friendly, cost effective and has excellent correlation to the existing commercial methods," said Dr. Chong Yuan, Managing Director of Diazyme Laboratories.

Diazyme Laboratories, Inc. is an affiliate of General Atomics, headquartered in La Jolla, California. Diazyme uses its unique 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, vitamins and nutritional assessments, liver disease, renal disease and electrolytes. Information regarding Diazyme's technologies and related products can be found on its website at www.diazyme.com.

For Further Information Contact:

Regulatory
Dr. Abhijit Datta, Ph.D 
Abhijit.Datta@diazyme.com

Sales
Douglas Borses
860-729-0121
Douglas.Borses@diazyme.com




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Source: General Atomics via Globenewswire

Source(s) : General Atomics

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