| ARCHITECT | 00380740001803 | Abbott Ireland, Diagnostics Division | Class C | |
| ARCHITECT Phenytoin | 00884883008397 | Microgenics Corporation | Unknown class | |
| Atellica CH Phenytoin (Phny) | 00630414596037 | Siemens Healthcare Diagnostics Inc. | Class C | |
| CEDIA Phenytoin II Assay | 00884883001220 | Microgenics Corporation | Unknown class | |
| Dimension Phenytoin Flex reagent cartridge | 00842768005619 | Siemens Healthcare Diagnostics Inc. | Class C | |
| Dimension Vista Phenytoin Flex reagent cartridge | 00842768015410 | Siemens Healthcare Diagnostics Inc. | Unknown class | |
| Emit 2000 Phenytoin Assay | 00842768017384 | Siemens Healthcare Diagnostics Inc. | Class C | |
| Emit® 2000 Phenytoin Assay | 00842768023217 | Siemens Healthcare Diagnostics Inc. | Class C | |
| IMMULITE 2000 Phenytoin | 00630414961903 | Siemens Healthcare Diagnostics Products Ltd. | Class C | |
| Phenytoin | 00380740102708 | Microgenics Corporation | Unknown class | |
| Phenytoin CLIA Kit (Chemiluminescence Immunoassay) | 06942293590568 | Beijing Diagreat Biotechnologies Co., Ltd. | Class C | |
| Phenytoin Determination Kit (Fluorescence Immunochromatographic Assay) | 06942293580576 | Beijing Diagreat Biotechnologies Co., Ltd. | Class C | |
| RapidFor™ Phenytoin Rapid Test Kit (FIA) | 08683548250384 | Vitrosens Biotechnology Inc. | Unknown class | |
UDI Compass