| ADVIA Centaur HER-2/neu | 00630414471235 | Siemens Healthcare Diagnostics Inc. | Class C | |
| Atellica IM HER-2/neu (H2n) | 00630414599151 | Siemens Healthcare Diagnostics Inc. | Class C | |
| HER-2/neu CLIA Microparticles | 06942359525473 | Autobio Diagnostics Co., Ltd. | Class C | |
| HER-2/neu CLIA Microparticles | 06942359550499 | Autobio Diagnostics Co., Ltd. | Class C | |
| HER-2/neu CLIA Microparticles | 06942359550512 | Autobio Diagnostics Co., Ltd. | Class C | |
| HOKAPI™ HER-2/NEU | 06939716404717 | Suzhou Hokapi Biomedical Engineering Co., Ltd.. | Class C | |
| HOKAPI™ HER-2/NEU | 06939716404724 | Suzhou Hokapi Biomedical Engineering Co., Ltd.. | Class C | |
| HOKAPI™ HER-2/NEU | 06971390439746 | Suzhou Hokapi Biomedical Engineering Co., Ltd.. | Class C | |
| Human Epidermal GrowthFactor Receptor 2（HER-2）Assay Reagent Kit (CMIA) | 06971792051416 | Hangzhou Realy Tech Co.,Ltd. | Unknown class | |
| Human Epidermal GrowthFactor Receptor 2（HER-2）Assay Reagent Kit (CMIA) | 06976753470572 | Hangzhou Cybereagen Biotech Co., Ltd. | Unknown class | |
UDI Compass