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Instrumentation Laboratory Receives 510(K) Clearance From FDA and Canadian License for HemosIL(R) D-Dimer HS 500 Assay
Date:2/23/2010

BEDFORD, Mass., Feb. 23 /PRNewswire/ -- Instrumentation Laboratory (IL) today announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its HemosIL D-Dimer HS 500 assay.  Additionally, the Company received a license from Health Canada for the product.  The Company will now initiate commercialization of HemosIL D-Dimer HS 500 in North America, with their distribution partner, Beckman Coulter, Inc.  In April 2009, the assay was previously released in Europe, after receiving the European CE IVD Mark.  

HemosIL D-Dimer HS 500 is a liquid, ready-to-use, automated latex-enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP® Family of Hemostasis Testing Systems for us
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