Navigation Links
Instrumentation Laboratory Receives 510(k) Clearance From FDA for HemosIL(R) Liquid Heparin Assay
Date:6/15/2009

- Ready-to-use, Chromogenic Assay for Monitoring UF and LMW Heparin -

BEDFORD, Mass., June 15 /PRNewswire/ -- Instrumentation Laboratory (IL) today announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its HemosIL Liquid Heparin assay. Previously, the Company received a license for the product from Health Canada, as well as a European CE IVD Mark. With this latest clearance in the US, the company can now initiate commercialization in North America and European countries. IL will coordinate commercialization of the product in North America, with their distribution partner, Beckman Coulter, Inc.

HemosIL Liquid Heparin is a liquid, ready-to-use, universal heparin assay for the quantitative determination of unfractionated heparin (UFH) and low-molecular weight heparin (LMWH) activity in human citrated plasma. Fully automated on IL Hemostasis Testing Systems, it is a one-stage chromogenic assay, with excellent correlation with traditional two-stage assays, providing greater simplicity and efficiency. This allows customers to move testing from the specialty lab to the routine lab, ensuring availability 24 hours/day, 7 days/week.

"We are very pleased with the rapid clearance of HemosIL Liquid Heparin by the FDA. This speaks to its significance to the medical community," said Giovanni Russi, Director of Marketing, Hemostasis Reagents at Instrumentation Laboratory. "It is an exciting breakthrough for healthcare providers who treat the thousands of patients around the world using UFH and LMWH. This will enable more rapid and accurate monitoring of prophylaxis and treatment."

Instrumentation Laboratory Receives 510(K) Clearance From FDA for HemosIL Liquid Heparin Assay

UFH and LMWH are widely used anticoagulants, administered for the prophylaxis and treatment of a number of cardiovascular disorders, including venous thromboembolism, unstable angina and acute myocardial infarction. They are also administered to patients who undergo orthopedic, cardiovascular and other surgeries. UFH and LMWH monitoring is critical in assessing and determining the appropriate anticoagulant activity in these patients. Due to the extensive number of such patients, the availability of a chromogenic anti-Xa assay, readily and always available is key in ensuring effective monitoring, 24 hours a day/7 day a week.

Instrumentation Laboratory (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(R) product offerings, part of the critical care line, include the GEM Premier(TM) 4000 analyzer with Intelligent Quality Management (iQM(R)), the new GEM Premier 3500 analyzer with iQM and the GEM PCL Plus, a portable coagulation analyzer. IL's hemostasis portfolio includes the ACL TOP(R) Family of Hemostasis Testing Systems, fully automated, high-productivity analyzers, including the ACL TOP and the new ACL TOP 500 CTS. IL also offers the new ACL AcuStar Hemostasis Testing System, the ACL ELITE(R) and ELITE PRO, other hemostasis analyzers and the HemosIL(R) line of reagents. IL is based in Bedford, Massachusetts.

The Instrumentation Laboratory logo, GEM, iQM, HemosIL, ACL, ACL TOP, ACL ELITE, ACL AcuStar, Premier and GEM OPL are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or parent companies, and may be registered in the United States Patent and Trademark Office and in other jurisdictions. All other product names, company names, marks, logos, and symbols are trademarks of their respective owners.


'/>"/>
SOURCE Instrumentation Laboratory
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Instrumentation Laboratory Launches ACL AcuStar(TM) Hemostasis Testing System
2. Instrumentation Laboratory Wins Patent Infringement and Unfair Competition Trial Against Diagnostica Stago Relating to Reagents for Hemostasis Diagnostics
3. Instrumentation Laboratory Wins Extended Agreement With MedAssets Supply Chain Systems for Critical Care Portfolio
4. Instrumentation Laboratory Announces ILeader Panel of Experts as Part of 50th Anniversary Program
5. Frost & Sullivan Recognizes Waters Corporation for Its Pioneering, High Customer Value Analytical Instrumentation Product, SYNAPT HDMS
6. Instrumentation Laboratory Receives Performance Award from Premier for Second Consecutive Year
7. Instrumentation Laboratory Launches ACL Top(R) 500 CTS Hemostasis Testing System
8. Beckman Coulter to Acquire Flow Cytometry Instrumentation Business From Dako
9. Instrumentation Laboratory Named Top of Class by Respiratory Care Managers
10. Legislation Will Expand Access to Life-Saving Laboratory Tests
11. Quest Diagnostics Introduces First Comprehensive Laboratory Test To Analyze KRAS, NRAS, and BRAF Gene Mutations in Reflex Testing Service
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/24/2017)... WA (PRWEB) , ... April 24, 2017 , ... ... leading lifestyle brands, work wear distributors and International relief organizations across the globe ... The company also offers lifestyle and work wear collections via insectshield.com . ...
(Date:4/22/2017)... ... April 22, 2017 , ... Ecommerce sales have grown ... estimated to be $394.9 billion. The consequences of rapid innovation and growth are ... limits of technology, it is every business and individual’s job to give something back ...
(Date:4/21/2017)... ... April 21, 2017 , ... An April 10 article in ... teeth, which reveal a great deal about prehistoric ice-age dental practitioners and their primitive ... been used to remove decayed dental matter, and that teeth were then filled with ...
(Date:4/21/2017)... ... April 21, 2017 , ... ... and young adults, has kicked off its 4th annual Forum for Innovative Treatment ... theme is “Attachment Informed Therapy for Mental Health and Addiction.” , FITS’ ...
(Date:4/21/2017)... , ... April 21, 2017 , ... The Patient Advocacy ... Health System, with the 2017 Ruth Ravich Patient Advocacy Award in recognition ... advocates. DeVaro was honored with the award at The Beryl Institute’s annual Patient ...
Breaking Medicine News(10 mins):
(Date:4/19/2017)... , April 19, 2017 ... an immune response in pets such as canine, ... are of various types such as Attenuated Live ... Vaccines, DNA Vaccines and Recombinant Vaccines. Attenuated live ... virus or bacteria, which have been weakend under ...
(Date:4/19/2017)... April 19, 2017  SARES•REGIS Group leased the ... developing at Conejo Spectrum Business Park in ... Atara Biotherapeutics, Inc. , a biopharmaceutical company developing ... diseases that have been underserved by scientific innovation, ... for cancer, autoimmune and infectious disease. ...
(Date:4/18/2017)... -- Viverae ® , a leader in workplace wellness ... ® Watson Campaign Automation, implementing behavioral messaging within ... personalized experience. Through digital engagement, the platform prompts members ... time. The enhanced experience drives engagement by focusing on ... are in their journey to health. ...
Breaking Medicine Technology: