Navigation Links
Instrumentation Laboratory Receives FDA Clearance for HemosIL RecombiPlasTin 2G Assay
Date:9/25/2007

- Second Generation Reagent for Blood Coagulation Testing -

LEXINGTON, Mass., Sept. 25 /PRNewswire/ -- Instrumentation Laboratory (IL) today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for HemosIL(R) RecombiPlasTin 2G. This new product is the second generation of HemosIL RecombiPlasTin, one of the most widely used Prothrombin Time (PT) reagents in the world.

HemosIL RecombiPlasTin 2G is performed for pre-surgical screening to evaluate the extrinsic coagulation pathway and to monitor oral anticoagulant therapy. It is based on recombinant tissue factor and a blend of synthetic phospholipids, which allow high sensitivity and lot-to-lot consistency. Additionally, the reagent is insensitive to the new antibiotic Cubicin (daptomycin for injection) and has an ISI value of approximately 1.0 on IL's ACL analyzers, traceable to WHO standards.

"RecombiPlasTin 2G is another example of IL's commitment to continuous product improvement and innovation," said Giovanni Russi, Director of Worldwide Marketing, Hemostasis Reagents at IL. "We are dedicated to delivering the best hemostasis and critical care diagnostics to healthcare providers and ultimately, contributing to the betterment of patient care."

Instrumentation Laboratory (http://www.ilus.com), founded in 1959, is a worldwide developer, manufacturer and distributor of in vitro diagnostic instruments, related reagents and controls for use primarily in hospitals and independent clinical laboratories. The company's product lines include critical care systems, hemostasis systems and information management systems. IL's GEM product offerings, part of the critical care line, include the new GEM Premier 4000 analyzer with Intelligent Quality Management (iQM(R)), GEM Premier 3000 analyzer, GEM OPL(TM), a portable whole blood CO-Oximeter and the GEM PCL Plus, a portable Coagulation analyzer. IL's hemostasis portfolio includes the ACL TOP(R), a fully automated, high-productivity analyzer and the ACL ELITE, the latest addition to the ACL family. IL also offers the HemosIL(R) line of reagents. IL is based in Lexington, Massachusetts.


'/>"/>
SOURCE Instrumentation Laboratory
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. New Quality Control Systems for Every Laboratory Application
2. Immunoassay Systems - Your Laboratory Workhorse
3. Sirion Therapeutics Receives Orphan Drug Designation for Ophthalmic Drug to Treat Viral Eye Infection
4. Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD
5. DUSA Pharmaceuticals Receives Orphan Drug Desi gnation for Levulan PDT to Treat Esophage al Dysplasia
6. Gloucester Pharmaceuticals Receives Fast Track Designation for Romidepsin in Peripheral T-Cell Lymphoma
7. When Volume Matters, Immunoassay Systems Deliver
8. New Assays to Detect Disseminated Fungal Infections
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) ... Improvements Act of 1976, as amended ("HSR"), with respect ... Nasdaq: CPXX ) expired effective June 24, ... As previously announced on May 31, 2016, Jazz Pharmaceuticals ... which Jazz Pharmaceuticals has commenced a tender offer for ...
(Date:6/24/2016)... June 24, 2016  Global Blood Therapeutics, Inc. (GBT) ... developing novel therapeutics for the treatment of grievous ... the closing of its previously announced underwritten public ... the public offering price of $18.75 per share. ... offered by GBT. GBT estimates net proceeds from ...
(Date:6/24/2016)... 2016 Dehaier Medical Systems Ltd. (NASDAQ: ... markets and sells medical devices and wearable sleep respiratory ... strategic cooperation agreement with Hongyuan Supply Chain Management Co., ... June 20, 2016, to develop Dehaier,s new Internet medical ... Dehaier will leverage Hongyuan Supply Chain,s sales platform to ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... , ... First Choice Emergency Room , the largest network of independent ... Director of its new Mesquite-Samuell Farm facility. , “We are pleased to announce ... Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether ... latter, setting the bar too high can result in disappointment, perhaps even self-loathing. However, ... their goal. , Research from PsychTests.com reveals that behind the tendency ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Marcy was in a crisis. Her son James, ... out at his family verbally and physically. , “When something upset him, he couldn’t control ... use it. He would throw rocks at my other children and say he was going ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San ... Society and the Road To Recovery® program to drive cancer patients to and from ... adults to ensure the highest quality of life and ongoing independence. Getting to ...
(Date:6/24/2016)... ... 24, 2016 , ... The Haute Beauty Network, affiliated with ... as a prominent plastic surgeon and the network’s newest partner. , Dr. ... handsome men, look naturally attractive. Plastic surgery should be invisible.” He stands by ...
Breaking Medicine News(10 mins):