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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 t
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SOURCE Instrumentation Laboratory
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