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.
ISO 13485: A certified manufacturer of medical devices for IVD use
TBG has established and manages a quality management system and maintains its effectiveness in accordance with the requirements of ISO 13485:2003, ISO 14971:2000 Standards, IVDD related standards and guidelines. HLA Typing Kits are manufactured in a GMP facility.
ISO 13485 Certificate
CE Certificate- Morgan HLA Typing Kits
CE0197 Certificate- Directive for IVD manufacturers
510K Substantial Equivalence
ASHI Certification for HLA Low and High Resolution Typing (NEW)