FDA clearance for Leucoflex CGP Leukocyte Reduction in-line Filter
Macopharma is pleased to announce FDA clearance on a supplemental new drug application (sNDA) for the “Leucoflex CGP Leukocyte Reduction in-line Filter”.
The “Leucoflex CGP in-line Filter” consists of a blood collection system with 70ml of CPD for the collection of 500±50ml of whole blood and 110ml of AS-1 Additive Solution and is intended for the leukocyte reduction of Red Blood Cells prepared from whole blood stored at 1 -6°C up to 24 hours after collection.
Macopharma has demonstrated for years its expertise in the field of in-line filtration. Our research teams have developed systems that simplify leukocyte reduction process which improve the quality of the recovered blood components, minimise the risks of alloimmunisation, febrile non haemolytic transfusion reactions, post operative infection, immunomodulation, viral contamination (CMV, HTLV…), bacterial contamination and potential white cell-associated prion load.
Macopharma USA, exclusive importer and distributor of Macopharma products in the USA, is proud to now offer the” Leucoflex CGP Leukocyte Reduction in-line Filter” as an efficient solution for cold filtration and high plasma recovery.