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Diagnostics
U.S. FDA grants clearance for immunoassay for diagnosing venous thrombembolism
July 24th, 2005
Instrumentation Laboratory (IL) announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its new HemosIL D-Dimer HS assay. This immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP Hemostasis Testing System, aids in the diagnosis of venous thromboembolism (VTE), deep vein thrombosis (DVT), and pulmonary embolism (PE). HemosIL D-Dimer HS delivers results in less than 5 minutes, is easy to use and has enhanced analytical sensitivity and minimized interferences from rheumatoid factor and hemoglobin. In a management study conducted at an external laboratory on VTE-suspected...
Source: Medical Letter on the CDC & FDA (2005-07-24)
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