TBG Biotechnology Corp.

TBG Biotechnology Corp. specializes in in vitro diagnostic (IVD) kits for human leukocyte antigen (HLA) typing. These include sequence-specific primer (SSP) and sequence-based typing (SBT) assays, such as the HLAssure SE and Morgan HLA SSP kits. The devices target specific HLA loci (e.g., HLA-A, HLA-B, HLA-DRB1, HLA-DQB1) and are designed for applications like organ transplantation, blood transfusion compatibility, autoimmune disease diagnostics, and drug hypersensitivity testing. The company’s focus is on molecular diagnostics for immunogenetics.

TBG Biotechnology Corp. is headquartered in Taiwan. The company’s location influences its regulatory compliance, such as registration in the EU’s eudamed database, which is relevant for devices marketed in the European Union.

TBG Biotechnology Corp.’s devices are listed in the eudamed database, which is the EU’s official registry for in vitro diagnostic (IVD) medical devices. This registration is required for devices marketed within the European Economic Area (EEA) to demonstrate compliance with EU IVD regulations.

TBG Biotechnology Corp.’s HLA typing kits are classified as Class C medical devices under EU regulations and fall under IVD Annex II List B. This classification applies to devices that pose a moderate risk, such as those used for HLA genotyping, which require specific conformity assessment procedures to ensure safety and performance before market placement.