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:5/24/2016)... OXFORD, England , May 24, 2016 ... Practice and Education in Clinical Neurophysiology  ... medical information products and services, today announced the launch ... , an open access journal that focuses on clinical ... latest research, case reports, clinical series, normal values and ...
(Date:5/23/2016)... India , May 23, 2016 ... report "Patient Handling Equipment Market by Product (Wheelchair, ... of Care (Bariatric Care, Critical Care, Wound), Accessories ... - Forecast to 2021", published by MarketsandMarkets, the ... USD 17.18 Billion by 2021 at a CAGR ...
(Date:5/23/2016)... 23, 2016 Transparency Market Research ... Pancreatic Insufficiency Market - Global Industry Analysis, Size, Share, ... to the report, the exocrine pancreatic insufficiency market is ... 2015 to 2023 to reach US$2.85 Bn by 2023. ... characterized by the deficiency of the exocrine pancreatic enzymes, ...
Breaking Medicine Technology:
(Date:5/25/2016)... ... May 25, 2016 , ... The World Molecular ... through Molecular Imaging.” The focus of ADDMI-IG will be geared towards how using ... pipeline issues. Through ADDMI-IG WMIS will provide a platform for productive discussions about ...
(Date:5/25/2016)... ... May 25, 2016 , ... TransactRx ... real time adjudication of medical service claims by Pharmacy Benefit Managers that were ... claims management software. The TransactRx Cross Benefit Clearinghouse receives standard professional medical claims ...
(Date:5/25/2016)... ... , ... For more than fifty years, we've suffered whiplash as each new scientific study seemed ... the latest nutritional advice – advice that was supposed to keep us healthy and slim. ... American adults are considered to be overweight and more than 1 in 3 adults are ...
(Date:5/25/2016)... ... May 25, 2016 , ... Consumer access to organic foods and ... Kashi®, a maker of whole grain cereals and other plant-based foods, will introduce the ... hard red winter wheat processed by Hesco/Dakota Organic Products. , The transitional designation means ...
(Date:5/24/2016)... ... May 24, 2016 , ... According to an article published ... randomly assigned to reduce the amount of calories they consumed by 25% experienced some ... weight enjoyed better sleep, improved quality of life, and enhanced sexual function compared to ...
Breaking Medicine News(10 mins):