Safety & Packaging
- Processed by FDA registered and AATB accredited tissue banks in Class 100 cleanrooms
- Strict donor screening for risk factors associated with infectious diseases and medical conditions that would rule out donation
- Donor serology testing by CLIA certified laboratories for:
- – HIV type 1
– HIV type 2
– HBV Surface Antigen
– HBV Core Antibody
– HCV Antibody
- – STS (Syphilis RPR/VDRL)
– Human T-Lymphotropic Virus 1
– Human T-Lymphotropic Virus 2
– HIV-1 RNA NAT
– HCV RNA NAT
- Process removes all living components and cell fragments eliminating immunogenicity
- Bacterial and viral log reduction via Tissue Sterilization Processes
- Validated, double-sterile barrier packaging
- Donor and Lot traceability on each label