Regulatory Information

CorneaGen’s labs maintain the highest levels of quality through active participation in and review by the Eye Bank Association of America (EBAA) and 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. Disclaimer: certificates below are in the process of being updated as SightLife Surgical transitions to CorneaGen.

 

CorneaGen – Seattle
EBAA Accreditation Certificate (Seattle, WA) valid through June 30, 2021
   
FDA Registration Certificate (Seattle, WA) valid through December 31, 2019
   
California Registration Certificate (Seattle, WA lab) valid through October 03, 2019
   
Florida Registration Certificate (Seattle, WA lab) valid through October 23, 2020
   
Health Canada Registration Certificate valid through December 31, 2019
   
Maryland Tissue Bank Permit (Seattle, WA lab) valid through June 30, 2020
   
New York State Tissue Bank License (Seattle, WA lab) valid through December 1, 2020
CorneaGen – Albuquerque
EBAA Accreditation Certificate (Albuquerque, NM lab) valid through November 30, 2020
   
   
CorneaGen – Baltimore
EBAA Accreditation Certificate (Baltimore, MD lab) valid through November 30, 2020
   
   
CorneaGen – Bethlehem
EBAA Accreditation Certificate (Bethlehem, PA lab) valid through November 30, 2020
   
FDA Registration Certificate (Bethlehem, PA lab) valid through December 31, 2019
   
California Registration Certificate (Bethlehem, PA lab) valid through October 03, 2019
   
Florida Registration Certificate (Bethlehem, PA lab) valid through January 12, 2021
   
Maryland Tissue Bank Permit (Bethlehem, PA lab) valid through June 30, 2019
   
New York State Tissue Bank License (Bethlehem, PA lab) valid through December 1, 2020
CorneaGen – Boston
EBAA Accreditation Certificate (Boston, MA lab) valid through June 30, 2021
   
New York State Tissue Bank License (Boston, MA lab) valid through April 1, 2021
CorneaGen – Irvine
EBAA Accreditation Certificate (Irvine, CA lab) valid through June 30, 2021
   
FDA Registration Certificate (Irvine, CA lab) valid through December 31, 2019
   
California Registration Certificate (Irvine,CA lab) valid through October 03, 2019
   
Florida Registration Certificate (Irvine,CA lab) valid through January 12, 2021
   
Maryland Tissue Bank Permit (Irvine, CA lab) valid through June 30, 2019
   
New York State Tissue Bank License (Irvine, CA lab) valid through December 1, 2020
CorneaGen – Richmond
EBAA Accreditation Certificate (Richmond, CA lab) valid through November 30, 2020
   
   
CorneaGen – San Antonio
EBAA Accreditation Certificate (San Antonio, TX lab) valid through June 30, 2020
   
   
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, 2019
   
California Registration Certificate (South San Francisco, CA lab) valid through October 03, 2019
   
Florida Registration Certificate (South San Francisco, CA lab) valid through January 12, 2021
   
Maryland Tissue Bank Permit (South San Francisco, CA lab)
   
New York State Tissue Bank License (South San Francisco, CA lab) valid through December 1, 2020
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, 2019
   
California Registration Certificate (Winston-Salem, NC lab) valid through October 03, 2019
   
CE Mark (Winston-Salem, NC lab) valid through April 20, 2020
   
Florida Registration Certificate (Winston-Salem, NC lab) valid through January 23, 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