Product Specifications
Validated pathogen reduction technology using E-Beam irradiation
Released against a validated T-Cell growth promotion assay
Available in bag format
Large donor pool lot sizes
Manufactured from outdated FDA/AABB approved apheresis platelet units
FDA master file, PMDA Certificate of SuitabilityUsed for manufacturing in US, EU, and other clinical trials globally
Manufactured under a certified ISO 9001:2015 Quality Management System
Example CoA and IFU
Shipping Box Dimensions: 23 x 19 x 19 in
Shipping Weight: 65 lbs