Instrumentation Laboratory has received US Food and Drug Administration’s approval for HemosIL® RecombiPlasTin 2G.
Instrumentation Laboratory announced that the US Food and Drug Administration has granted 510(k) clearance for HemosIL® RecombiPlasTin 2G. This new product is the second generation of HemosIL RecombiPlasTin. HemosIL RecombiPlasTin 2G is performed for pre-surgical screening to evaluate the extrinsic coagulation pathway and to monitor oral anticoagulant therapy. It is based on recombinant tissue factor and a blend of synthetic phospholipids, which allow high sensitivity and lot-to-lot consistency. Additionally, the reagent is insensitive to the new antibiotic Cubicin (daptomycin for injection) and has an ISI value of approximately 1.0 on IL's ACL analyzers, traceable to WHO standards.