
圣地亞哥, 2018年1月22日 (全球新聞專(zhuān)線(xiàn)) – DIAZYME(德才姆)實(shí)驗(yàn)室今天宣布,美國(guó)食品藥物管理局已經(jīng)批準(zhǔn)其在市場(chǎng)上銷(xiāo)售應(yīng)用于生化儀上的簡(jiǎn)捷維生素D測(cè)試。DIAZYME實(shí)驗(yàn)室的雙試劑簡(jiǎn)捷維生素D測(cè)試是唯一可以在生化儀上使用的全自動(dòng)的維生素D測(cè)試雙試劑。
"DIAZYME實(shí)驗(yàn)室的維生素D測(cè)試是全自動(dòng)的,專(zhuān)門(mén)為普通的全自動(dòng)生化儀設(shè)計(jì)。這套穩(wěn)定的隨時(shí)可用的液體雙試劑測(cè)試的是總的25羥基維生素D (維生素D2 + D3)的水平。這套試劑的成功問(wèn)世使得幾乎所有的臨床實(shí)驗(yàn)室都可以自己檢測(cè)維生素D,而不需要昂貴的專(zhuān)用儀器。由于樣本不需要預(yù)處理或者預(yù)稀釋?zhuān)@款高通量的測(cè)試結(jié)果更加準(zhǔn)確,操作更加簡(jiǎn)便,成本也更加低廉,而且和現(xiàn)有的檢測(cè)方法有著極高的相關(guān)性。" DIAZYME公司總經(jīng)理袁博士介紹道。
DIAZYME實(shí)驗(yàn)室是美國(guó)通用原子公司(總部設(shè)在美國(guó)加州拉霍亞市)的子公司。DIAZYME實(shí)驗(yàn)室采用其獨(dú)特的平臺(tái)技術(shù),研發(fā)創(chuàng)新的性?xún)r(jià)比高的試劑供臨床和研究使用。其產(chǎn)品包括心臟標(biāo)志物,糖尿病,維生素及營(yíng)養(yǎng)測(cè)評(píng),肝功,腎功和電解質(zhì)等血液診斷試劑。關(guān)于DIAZYME實(shí)驗(yàn)室的技術(shù)和相關(guān)產(chǎn)品,請(qǐng)參閱網(wǎng)站 www.diazyme.com.
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法規(guī)負(fù)責(zé)人
Abhijit Datta博士
Abhijit.Datta@diazyme.com
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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
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