Licenses & Accreditation
Building a family with donor sperm means choosing a partner you can count on. Cryomate sperm bank operates as a fully accredited, FDA-registered tissue establishment dedicated to the highest safety standards 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 state-level tissue banking licensure to ensure full authorization for donor gamete distribution.
Cryomate Licenses & Accreditation
FDA Registration
Cryomate 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).
CAP License
College of American Pathologists
Cryomate maintains a CAP license, demonstrating our commitment to excellence in laboratory practices and quality control.
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.
CLIA License
Clinical Laboratory Improvement Amendments
As we operate in Indiana, Cryomate’s CLIA license affirms our adherence to rigorous standards set forth for clinical laboratory testing and quality assurance.
