圣地亚哥, 2018年1月22日 (全球新闻专线) – DIAZYME（德才姆）实验室今天宣布，美国食品药物管理局已经批准其在市场上销售应用于生化仪上的简捷维生素D测试。DIAZYME实验室的双试剂简捷维生素D测试是唯一可以在生化仪上使用的全自动的维生素D测试双试剂。

"DIAZYME实验室的维生素D测试是全自动的，专门为普通的全自动生化仪设计。这套稳定的随时可用的液体双试剂测试的是总的25羟基维生素D (维生素D2 + D3)的水平。这套试剂的成功问世使得几乎所有的临床实验室都可以自己检测维生素D，而不需要昂贵的专用仪器。由于样本不需要预处理或者预稀释，这款高通量的测试结果更加准确，操作更加简便，成本也更加低廉，而且和现有的检测方法有着极高的相关性。" DIAZYME公司总经理袁博士介绍道。

DIAZYME实验室是美国通用原子公司(总部设在美国加州拉霍亚市)的子公司。DIAZYME实验室采用其独特的平台技术，研发创新的性价比高的试剂供临床和研究使用。其产品包括心脏标志物，糖尿病，维生素及营养测评，肝功，肾功和电解质等血液诊断试剂。关于DIAZYME实验室的技术和相关产品，请参阅网站 www.diazyme.com.

获取更多资讯，请联系:

法规负责人
Abhijit Datta博士 
Abhijit.Datta@diazyme.com

销售负责人
Douglas Borses
860-729-0121
Douglas.Borses@diazyme.com

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

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January 22, 2018 09:00 ET | Source: General Atomics

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