Testing & Quality
Committed to rigorous screening, quality assurance, and responsible manufacturing.
Quality Commitment Heading Testing & Quality Guidelines
Every donor tissue undergoes rigorous screening, including medical and social history review. Each product is then tested for sterility, endotoxins, and environmental exposure either by our internal quality assurance team or a certified third-party CLIA laboratory.
Testing Standards
Testing Standards
Testing Includes USP 71 Sterility Testing – Fungus, mold, yeast, and bacteria Aseptic Processing Controls Endotoxin & Environmental Testing
Pathogen Screening
Screening for pathogens including (but not limited to): HIV I/II HBV HCV HTLV I/II TSE CJD Treponema pallidum WNV CMV Zika Lyme disease Epstein-Barr Candida E. coli COVID-19 For a complete list of testing, please contact your Cellcura representative.
Regulatory Information
Please note: Cellcura’s products are not FDA approved and may only be used in the State of Utah, in accordance with Section 58-1-512 of the Utah Code (Enacted Utah Senate Bill 199) and HRC 17 guidance. Healthcare providers are responsible for ensuring regulatory compliance at all times.
Screening Process
Phase One: Donor Screening
This initial phase involves comprehensive screening measures to evaluate donor tissues and establish a baseline for safety and compliance.
Phase Two: Sterility Testing
This phase details our advanced sterility testing procedures, ensuring every tissue sample meets the highest manufacturing standards.
Regulatory Information
This final standard demonstrates our commitment to responsibility, ensuring full adherence to all safety and manufacturing regulations.
Request Product Information
Contact our team for product details, testing documentation, and provider access.