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. Below, view or download copies of our registration and accreditation.


     

CorneaGen – Seattle (HQ)
EBAA Accreditation Certificate (Seattle, WA) valid through June 30, 2021
   
FDA Registration Certificate (Seattle, WA) valid through December 31, 2020
   
California Registration Certificate (Seattle, WA lab) valid through October 02, 2020
   
Florida Registration Certificate (Seattle, WA lab) valid through October 23, 2020
   
Illinois Registration Certificate (Seattle, WA lab) valid through May 1, 2021
   
Maryland Tissue Bank Permit (Seattle, WA lab) 
   
New York State Tissue Bank License (Seattle, WA lab) valid through November 1, 2021
   
Oregon Health Authority Registration (Seattle, WA lab) valid through February 28, 2023
   
CorneaGen – Albuquerque
EBAA Accreditation Certificate (Albuquerque, NM lab) valid through November 30, 2020
   
FDA Registration Certificate (Albuquerque, NM lab) valid through December 31, 2020
   
California Registration Certificate (Albuquerque, NM lab) valid through January, 31, 2021
   
Florida Registration Certificate (Albuquerque, NM lab) valid through March 7, 2021
   
Illinois Registration Certificate (Albuquerque, NM lab) valid through May 1, 2021
   
Maryland Tissue Bank Permit (Albuquerque, NM lab) 
   
New York State Tissue Bank License (Albuquerque, NM lab) valid through May 1, 2021
   
Oregon Health Authority Registration (Albuquerque, NM lab) valid through March 15, 2022
   
CorneaGen – Baltimore
EBAA Accreditation Certificate (Baltimore, MD lab) valid through November 30, 2020
   
FDA Registration Certificate (Baltimore, MD lab) valid through December 31, 2020
   
California Registration Certificate (Baltimore, MD lab) valid through February 27, 2021
   
Florida Registration Certificate (Baltimore, MD lab) valid through April 21, 2021
   
Illinois Registration Certificate (Baltimore, MD lab) valid through May 1, 2021
   
Maryland Tissue Bank Permit (Baltimore, MD lab) 
   
New York State Tissue Bank License (Baltimore, MD lab) valid through May 1, 2021
   
Oregon Health Authority Registration (Baltimore, MD lab) valid through March 15, 2022
   
CorneaGen – Boston
EBAA Accreditation Certificate (Boston, MA lab) valid through June 30, 2021
   
FDA Registration Certificate (Boston, MA lab) valid through December 31, 2020
   
California Registration Certificate (Boston, MA lab) valid through February 27, 2021
   
Florida Registration Certificate (Boston, MA lab) valid through April 21, 2021
   
Illinois Registration Certificate (Boston, MA lab) valid through May 1, 2021
   
Maryland Tissue Bank Permit (Boston, MA lab) 
   
New York State Tissue Bank License (Boston, MA lab) valid through April 1, 2021
   
Oregon Health Authority Registration (Boston, MA lab) valid through March 15, 2022
   
CorneaGen – Irvine
EBAA Accreditation Certificate (Irvine, CA lab) valid through June 30, 2021
   
FDA Registration Certificate (Irvine, CA lab) valid through December 31, 2020
   
California Registration Certificate (Irvine,CA lab) valid through October 02, 2020
   
Florida Registration Certificate (Irvine,CA lab) valid through January 12, 2021
   
Illinois Registration Certificate (Irvine,CA lab) valid through May 1, 2021
   
Maryland Tissue Bank Permit (Irvine, CA lab)
   
New York State Tissue Bank License (Irvine, CA lab) valid through November 1, 2021
   
Oregon Health Authority Registration (Irvine, CA lab) valid through February 27, 2023
   
CorneaGen – Orlando
EBAA Accreditation Certificate (Orlando, FL lab) valid through June 30, 2022
   
FDA Registration Certificate (Orlando, FL lab) valid through December 31, 2020
   
California Registration Certificate (Orlando, FL lab) valid through February 27, 2021
   
Florida Registration Certificate (Orlando, FL lab) valid through April 21, 2021
   
Illinois Registration Certificate (Orlando, FL lab) valid through May 1, 2021
   
Maryland Tissue Bank Permit (Orlando, FL lab) 
   
New York State Tissue Bank License (Orlando, FL lab) valid through November 1, 2021
   
Oregon Health Authority Registration (Orlando, FL lab) valid through March 15, 2022
   
CorneaGen – San Antonio
EBAA Accreditation Certificate (San Antonio, TX lab) valid through June 30, 2020
   
FDA Registration Certificate (San Antonio, TX lab) valid through December 31, 2020
   
California Registration Certificate (San Antonio, TX lab) valid through February 5, 2021
   
Florida Registration Certificate (San Antonio, TX lab) valid through January 21, 2021
   
Illinois Registration Certificate (San Antonio, TX lab) valid through May 1, 2021
   
Maryland Tissue Bank Permit (San Antonio, TX lab) 
   
New York State Tissue Bank License (San Antonio, TX lab) valid through May1, 2021
   
Oregon Health Authority Registration (San Antonio, TX lab) valid through March 15, 2022
   
CorneaGen – San Francisco
EBAA Accreditation Certificate (South San Francisco, CA lab) valid through June 30, 2021
   
FDA Registration Certificate (South San Francisco, CA lab) valid through December 31, 2020
   
California Registration Certificate (South San Francisco, CA lab) valid through October 02, 2020
   
Florida Registration Certificate (South San Francisco, CA lab) valid through January 12, 2021
   
Illinois Registration Certificate (South San Francisco, CA lab) valid through May 1, 2021
   
Maryland Tissue Bank Permit (South San Francisco, CA lab)
   
New York State Tissue Bank License (South San Francisco, CA lab) valid through November 1, 2021
   
Oregon Health Authority Registration (South San Francisco, CA lab) valid through February 28, 2023
   
CorneaGen – Winston-Salem
EBAA Accreditation Certificate (Winston-Salem, NC lab) valid through June 30, 2020
   
FDA Registration Certificate (Winston-Salem, NC lab) valid through December 31, 2020
   
California Registration Certificate (Winston-Salem, NC lab) valid through October 02, 2020
   
CE Mark (Winston-Salem, NC lab) valid through May 26, 2024
   
Florida Registration Certificate (Winston-Salem, NC lab) valid through January 23, 2021
   
Illinois Registration Certificate (Winston-Salem, NC lab) valid through May 1, 2021
   
ISO Cert (Winston-Salem, NC lab) valid through February 15, 2022
   
Maryland Tissue Bank Permit (Winston-Salem, NC lab)
   
New York State Tissue Bank License (Winston-Salem, NC lab) valid through March 1, 2021
   
Oregon Health Authority Registration (Winston-Salem, NC lab) valid through February 28, 2023