About Cook General Biotechnology (Who is producing HemaXellerate I)


Commitment to Quality

Cook General BioTechnology, LLC (CGBT) takes quality very seriously. Our employees have extensive ongoing training. CGBT is following or exceeds regulatory standards through compliance with leading industry and association certifications.

CGBT is FDA registered as an Human Cell & Tissue Products establishment, and is licensed in Indiana as a blood center. The umbilical cord blood processing laboratories are licensed in New York, New Jersey, Maryland, California, and Illinois. The cord blood program is also accredited by the American Association of Blood Banks. CGBT is FDA registered and holds a Certificate of Compliance under CLIA granted by CMS.

CGBT also participates in the Better Business Bureau BBBOnLine Reliability Program and is a member of the Indianapolis Chamber of Commerce.

Certificates and Accreditations
American Association of Blood Banks - AABB Accreditation
Food and Drug Administration - FDA HCT/Ps Registration
Centers for Medicare & Medicaid Services - Clinical Laboratory Improvement Amendements (CLIA)
Indiana State Department of Health - Blood Center Program Approval of Operation
New Jersey Department of Health - Blood Bank License
New York State Department of Health - Provisional Licenses for Tissue Bank Operation, Genesis Bank Cord Blood Procurement License, Genesis Bank Cord Blood Processing License, and Genome Resources Provisional License for Tissue Bank Operation
Maryland Department of Health And Mental Hygiene - Medical Laboratory Permit
Maryland Department of Health And Mental Hygiene - Tissue Bank Permit
California Department of Public Health - Cord Blood Permit

http://www.cookgbt.com/