FDA Registration
Registration # 3004092640 -view
CryoGam Colorado, LLC is currently registered with the FDA as an HCT/P establishment. CryoGam agrees to maintain FDA registration as required and will remain compliant with the applicable regulations of 21 CFR 1271 regarding the manufacturing and distribution of all HCT/Ps.

CLIA
ID # 06D0859189 - view
The US Department of Health and Human Services created the Clinical Laboratory Improvement Act (CLIA) of 1988 to establish standards that apply to almost all laboratory testing of human semen specimens, laboratory personnel, quality control and quality assurance. CryoGam is inspected and certified by CLIA every 2 years.
Many states do not regulate sperm banks, including Colorado. New York and California are two states that require sperm bank licensure in order to do business within their state. CryoGam has completed the licensure process for both New York and California.

New York State Department of Health
License # GA051 - view
CryoGam is inspected and licensed by the New York State Department of Health. The New York State Department of Health is an outstanding organization that maintains public safety by doing unannounced inspections every 2 years. If a bank fails to meet their standards, the New York State Department of Health may revoke a bank's license.

State of California Department of Health Services
License # CTB00080446 - view
CryoGam is licensed by the State of California Department of Health Services. California requires sperm banks to update their licensure annually and may perform unannounced inspections. If a bank fails to meet their standards, the State of California Department of Health Services may revoke a tissue bank's license.

Maryland Department of Health and Mental Hygiene
License # TB1723 - view
CryoGam is licensed by the Maryland Department of Health and Mental Hygiene Office of Health Care Quality. If a bank fails to meet their standards, Maryland Department of Health may revoke a tissue bank's license.

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Oregon Health Authority

Tissue Bank Registration - view 

CryoGam is registered with the Oregon Health Authority's Office of Health Care Regulation and Quality Improvement as an official tissue bank. 

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