Free Submission Public Relations & NewsPR-inside.com
Home
Deutsch English

Business

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


Print article Print article
© Marketwire 2013
2013-02-12 22:13:03 -

SAN DIEGO, CA -- (Marketwire) -- 02/12/13 -- Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its D-Dimer assay. In line with current clinical needs, Diazyme's D-Dimer latex-enhanced immunoturbidimetric assay can be utilized to measure total levels of D-Dimer in plasma samples as part of a work up of patients with blood clotting issues. Utilization of this technology allows for highly reliable and precise test results, with minimal sample volumes. The D-Dimer assay is both fast and flexible with complete test results in minutes. Furthermore, the assay has been designed to work on most high throughput clinical chemistry analyzers, allowing users faster results and improved laboratory workflow.





Diazyme's D-Dimer assay is an important new tool to aid in detecting the presence of intravascular coagulation and fibrinolysis. By quantitatively determining the concentration of the clotting proteins such as fibrinogen and fibrin degradation products (D-Dimer) in human plasma, Diazyme's new assay can assist in the evaluation of patients with abnormal clotting.



"Diazyme's D-Dimer assay provides a precise, flexible and cost effective test method for laboratories of virtually all sizes," said Dr. Chong Yuan, Managing Director of Diazyme Laboratories. "The sensitivity of the assay allows D-Dimer levels to be measured very efficiently and effectively."



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 : ctt.marketwire.com/?release=985026&id=2606950&type=1& .. .




For Further Information Contact:

Diazyme Laboratories:
Douglas Borses
860-729-0121
Email Contact : www2.marketwire.com/mw/emailprcntct?id=38502D8B9E24F1D9

Public Relations:
Doug Fouquet
(858) 455-2173
Email Contact : www2.marketwire.com/mw/emailprcntct?id=746A29B32C8096B1



Press Information:




Contact Person:


Disclaimer: (c) 2014 Market Wire. All of the press releases contained herein are protected by copyright and other applicable laws, treaties and conventions. Information contained in the releases is furnished by Market Wire's, who warrant that they are solely responsible for the content, accuracy and originality of the information contained therein. All reproduction, other than for an individual user's personal reference, is prohibited without prior written permission.
Latest News
Read the Latest News
www.newsenvoy.com

 


Terms & Conditions | Privacy | About us | Contact PR-inside.com | BidVertiser