Licenses & Accreditation
Cryomate operates as a fully accredited, FDA-registered tissue establishment dedicated to the highest standards of safety in third-party reproduction. Our laboratory is regularly inspected and maintains rigorous compliance with all US federal regulations (21 CFR 1271), CLIA laboratory standards, and Health Canada’s Safety of Sperm and Ova Regulations. We also maintain comprehensive tissue banking licensure at the state level to ensure full authorization for donor gamete distribution.
Our Licenses and accreditations
FDA Registration
Our registration with the U.S. Food and Drug Administration (FDA) underscores our compliance with 21 CFR Part 1271 regarding the strict eligibility, screening, and testing of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).
CLIA License
(Clinical Laboratory Improvement Amendments)
As we operate within Indiana, our CLIA license affirms our adherence to the rigorous standards set forth for clinical laboratory testing and quality assurance.
CAP License
(College of American Pathologists)
Cryomate Donor Bank maintains a CAP license, demonstrating our commitment to excellence in laboratory practices and quality control.
Tissue Banking Regulations
Cryomate Donor Bank adheres to the stringent regulations governing tissue banking in the states of New York, California, Delaware, Illinois, Maryland, Oregon, and Colorado, guaranteeing an uncompromising commitment to safety and quality for both our valued donors and recipients.
Health Canada Registration
Cryomate holds a Health Canada Registration Certificate in accordance with the Safety of Sperm and Ova Regulations. This authorizes our distribution within Canada and affirms our compliance with federal safety standards.
For those seeking additional genetic testing beyond our standard panels, Cryomate’s team is here to assist and coordinate the process. Please reach out to info@cryomate.com to explore additional testing options for any of our donors.
