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FDA Clears Siemens Coagulation Products

NEW YORK (360Dx) – The US Food and Drug Administration has cleared several blood coagulation-related products made by Siemens Healthcare Diagnostics for the Sysmex CS-2100i system.

The agency late last month issued 510(k) clearance for Siemens' coagulation factor V deficient plasma; coagulation factor II, VII, and X deficient plasmas; protein C reagent; and Berichrom protein C. The company can now market the products in the US.

Coagulation factor V deficient plasma is an in vitro diagnostic reagent for determining the activity of coagulation factor V in human plasma, while coagulation factor VII deficient plasma is an IVD reagent for assessing the activity of coagulation factor II, or prothrombin, coagulation factor VII, and coagulation factor X in human plasma by coagulometric methods.

Protein C reagent is a coagulation test for quantitatively determining protein C levels in human plasma, while Berichrom protein C is a coagulation test to quantitatively measure protein C activity in human plasma.

The Sysmex CS-2100i is an automated blood coagulation instrument for the analysis of large sample volumes by clotting, chromogenic, and immunoassay methods.