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About TBG

Quality Systems

Quality Policy

Quality is at the heart of what we do. From operations management to product design and manufacture we have instituted a comprehensive quality management system to monitor and constantly improve our products and services.

TBG is an ISO13485 Certified Manufacturer of IVD products.

ISO 13485 Certificate (TBG Biotechnology Corp.)

SO 13485 Certificate (TBG Biotechnology (Xiamen) Inc.)

TBG's SBT and SSP typing products are
also CE-marked and US FDA 510K cleared:

CE Certificate- Morgan HLA SBT and SSP Typing Kits

510K Substantial Equivalence for Morgan SSP Typing Kits

TBG Laboratory is also accredited by the American Society
of Histocompatibility and Immunogenetics:

ASHI Certification for HLA Low and High Resolution
Typing New