Heparin Assay Is Fully Automated on Hemostasis Testing Systems

The HemosIL liquid heparin assay is a liquid, ready-to-use, assay universal heparin assay for the quantitative determination of unfractionated heparin (UFH) and low-molecular weight heparin (LMWH) activity in human citratedplasma. 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 to the routine lab from the specialty lab, ensuring availability 24 hours/day, 7 days/week. The assay can be performed on the ACL TOP Family, ACL Elite/Elite Pro/8/9/10000, and ACL Futura/ACL Advance.

The U.S. Food and Drug Administration (Silver Spring, MD, USA) has granted Instrumentation Laboratory Company Inc. (IL; Lexington, MA, USA) 510(k) clearance for the HemosIL liquid heparin assay. Previously, the company received a license for the product from Health Canada, as well as a European CE in vitro diagnostics (IVD) mark. With the US clearance, the company will initiate commercialization of the HemosIL assay in North America and European countries. IL will coordinate commercialization of the product in North America, with its distribution partner, Beckman Coulter Inc. (Fullerton, CA, USA).

Instrumentation Laboratory Company, Inc. develops, manufactures, and distributes in vitro diagnostic instruments, reagents, supplies, and controls for hospitals and independent clinical laboratories. The company offers blood testing, microcoagulation, quality control, and coagulation analyzer systems, as well as a Windows application that consolidates data.

Related Links:
U.S. Food and Drug Administration
Instrumentation Laboratory Company Inc.
Beckman Coulter Inc.