Regulatory Information
CorneaGen’s labs maintain the highest levels of quality through review by the U.S. Food and Drug Administration.
For more information, please contact our Quality Assurance and Regulatory Affairs Department at (877) 682-8502.
Seattle (HQ)
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EBAA Accreditation Certificate (Seattle, WA) valid through June 30, 2027
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FDA Registration Certificate (Seattle, WA) valid through December 31, 2025
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California Registration Certificate (Seattle, WA lab) valid through April 03, 2026
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Florida Registration Certificate (Seattle, WA lab) valid through January 21, 2027
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Illinois Registration Certificate (Seattle, WA lab) valid through May 1, 2026
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Maryland Tissue Bank Permit (Seattle, WA lab)
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New York State Tissue Bank License (Seattle, WA lab) valid through January 1, 2026
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Oregon Health Authority Registration (Seattle, WA lab) valid through February 28, 2026
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Delaware Tissue Bank Registration (Seattle, WA lab) valid through April 30, 2026
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Health Canada CTO Registration (Seattle, WA lab) valid through December 31, 2026
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Albuquerque
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EBAA Accreditation Certificate (Albuquerque, NM lab) valid through June 30, 2027
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FDA Registration Certificate (Albuquerque, NM lab) valid through December 31, 2025
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California Registration Certificate (Albuquerque, NM lab) valid through January 31, 2026
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Florida Registration Certificate (Albuquerque, NM lab) valid through June 5, 2027
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Illinois Registration Certificate (Albuquerque, NM lab) valid through May 1, 2026
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Maryland Tissue Bank Permit (Albuquerque, NM lab)
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New York State Tissue Bank License (Albuquerque, NM lab) valid through May 1, 2027
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Oregon Health Authority Registration (Albuquerque, NM lab) valid through February 15, 2028
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Delaware Tissue Bank Registration (Albuquerque, NM lab) valid through April 30, 2026
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Baltimore
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FDA Registration Certificate (Baltimore, MD lab) valid through December 31, 2025
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California Registration Certificate (Baltimore, MD lab) valid through April 3, 2026
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Florida Registration Certificate (Baltimore, MD lab) valid through April 21, 2027
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Illinois Registration Certificate (Baltimore, MD lab) valid through May 1, 2026
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Maryland Tissue Bank Permit (Baltimore, MD lab)
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New York State Tissue Bank License (Baltimore, MD lab) valid through January 1, 2026
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Oregon Health Authority Registration (Baltimore, MD lab) valid through March 15, 2028
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Delaware Tissue Bank Registration (Baltimore, MD lab) valid through April 30, 2026
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Boston
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EBAA Accreditation Certificate (Boston, MA lab) valid through June 30, 2027
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FDA Registration Certificate (Boston, MA lab) valid through December 31, 2025
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California Registration Certificate (Boston, MA lab) valid through April 3, 2026
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Florida Registration Certificate (Boston, MA lab) valid through April 21, 2027
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Illinois Registration Certificate (Boston, MA lab) valid through May 1, 2026
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Maryland Tissue Bank Permit (Boston, MA lab)
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New York State Tissue Bank License (Boston, MA lab) valid through January 1, 2026
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Oregon Health Authority Registration (Boston, MA lab) valid through March 15, 2028
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Delaware Tissue Bank Registration (Boston, MA lab) valid through April 30, 2026
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Irvine
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FDA Registration Certificate (Irvine, CA lab) valid December 31, 2025
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California Registration Certificate (Irvine, CA lab) valid through April 03, 2026
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Florida Registration Certificate (Irvine, CA lab) valid through April 12, 2027
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Illinois Registration Certificate (Irvine, CA lab) valid through May 1, 2026
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Maryland Tissue Bank Permit (Irvine, CA lab)
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New York State Tissue Bank License (Irvine, CA lab) valid through January 1, 2026
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Oregon Health Authority Registration (Irvine, CA lab) valid through February 28, 2026
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Delaware Tissue Bank Registration (Irvine, CA lab) valid through April 30, 2026
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Orlando
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EBAA Accreditation Certificate (Orlando, FL lab) valid through June 30, 2027
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FDA Registration Certificate (Orlando, FL lab) valid through December 31, 2025
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California Registration Certificate (Orlando, FL lab) valid through April 3, 2026
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Florida Registration Certificate (Orlando, FL lab) valid through April 21, 2027
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Illinois Registration Certificate (Orlando, FL lab) valid through May 1, 2026
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Maryland Tissue Bank Permit (Orlando, FL lab)
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New York State Tissue Bank License (Orlando, FL lab) valid through July 1, 2026
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Oregon Health Authority Registration (Orlando, FL lab) valid through March 15, 2028
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Delaware Tissue Bank Registration (Orlando, FL lab) valid through April 30, 2026
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San Antonio
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EBAA Accreditation Certificate (San Antonio, TX lab) valid through October 31, 2026
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FDA Registration Certificate (San Antonio, TX lab) valid through December 31, 2025
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California Registration Certificate (San Antonio, TX lab) valid through February 6, 2026
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Florida Registration Certificate (San Antonio, TX lab) valid through April 21, 2027
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Illinois Registration Certificate (San Antonio, TX lab) valid through May 1, 2026
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Maryland Tissue Bank Permit (San Antonio, TX lab)
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New York State Tissue Bank License (San Antonio, TX lab) valid through June 1, 2027
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Oregon Health Authority Registration (San Antonio, TX lab) valid through February 15, 2028
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Delaware Tissue Bank Registration (San Antonio, TX lab) valid through April 30, 2026
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San Francisco
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EBAA Accreditation Certificate (South San Francisco, CA lab) valid through June 30, 2027
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FDA Registration Certificate (South San Francisco, CA lab) valid through December 31, 2025
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California Registration Certificate (South San Francisco, CA lab) valid through April 03, 2026
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Florida Registration Certificate (South San Francisco, CA lab) valid through April 12, 2027
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Illinois Registration Certificate (South San Francisco, CA lab) valid through May 1, 2026
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Maryland Tissue Bank Permit (South San Francisco, CA lab)
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New York State Tissue Bank License (South San Francisco, CA lab) valid through September 1, 2026
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Oregon Health Authority Registration (South San Francisco, CA lab) valid through February 28, 2026
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Delaware Tissue Bank Registration (South San Francisco, CA lab) valid through April 30, 2026
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Winston-Salem
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California Registration Certificate (Winston-Salem, NC lab) valid through April 03, 2026
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FDA Registration Certificate (Winston-Salem, NC lab) valid through December 31, 2025
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CE Mark (Winston-Salem, NC lab) MDR Extension through December 31, 2028
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Florida Registration Certificate (Winston-Salem, NC lab) valid through April 23, 2027
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Illinois Registration Certificate (Winston-Salem, NC lab) valid through May 1, 2026
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ISO Cert (Winston-Salem, NC lab) valid through February 15, 2028
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Maryland Tissue Bank Permit (Winston-Salem, NC lab)
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New York State Tissue Bank License (Winston-Salem, NC lab) valid through June 1, 2026
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Oregon Health Authority Registration (Winston-Salem, NC lab) valid through February 28, 2026
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Delaware Tissue Bank Registration (Winston-Salem, NC lab) valid through April 30, 2026
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