| IMMULITE 2000 AFP | 00630414961040 | Siemens Healthcare Diagnostics Products Ltd. | Class C | |
| LIAISON® AFP | 08056771200479 | DiaSorin Italia S.p.A. | Unknown class | |
| Rapid AFP Test Card | 06921963717092 | Xiamen Boson Biotech Co., Ltd. | Unknown class | |
| RapidFor™ | 08683347941506 | Vitrosens Biotechnology Inc. | Class C | |
| RapidFor™ | 08684998273831 | Vitrosens Biotechnology Inc. | Class C | |
| RG-AFP | 03770024321340 | Cisbio Bioassays | Unknown class | |
| Sharay AFP (CLIA) | 06975070763039 | C-Luminary Biotechnology Co., Ltd. | Unknown class | |
| SmarLumi | 06933289859257 | Guangzhou Wondfo Biotech Co., Ltd. | Unknown class | |
| SmarLumi | 06933289859264 | Guangzhou Wondfo Biotech Co., Ltd. | Unknown class | |
| SmarLumi | 06933289859271 | Guangzhou Wondfo Biotech Co., Ltd. | Unknown class | |
| SmarLumi | 06933289859288 | Guangzhou Wondfo Biotech Co., Ltd. | Unknown class | |
| ST AIA-PACK AFP | 14560189210230 | Tosoh Corporation | Unknown class | |
| SuperFlex AFP Kit | 06951045811530 | Suzhou Sym-Bio Lifescience Co., Ltd. | Class C | |
| TruVue | 15065023763655 | BioFynder Limited | Unknown class | |
| VIDAS® AFP | 03573026064990 | bioMérieux SA | Class C | |
| VITROS™ ECL Alpha-Fetoprotein Assay | 06978139076132 | Shenzhen Lifotronic Technology Co., Ltd. | Class C | |
| α1-fetoprotein AFP assay Kit | 06954376012331 | Beijing Leadman Biochemistry Co., Ltd. | Unknown class | |
| α-Fetoprotein Kit (Latex-Enhanced Immunoturbidimetric Method) | 06936595750249 | MedicalSystem Biotechnology Co., Ltd. | Unknown class | |
| α-fetoprotein test (Chemiluminescence Immunoassay) | 06936700404661 | Beijing Hotgen Biotech Co., Ltd. | Class C | |
| α-fetoprotein test (Up-converting Phosphor Technology) | 06936700405644 | Beijing Hotgen Biotech Co., Ltd. | Class C | |
| μTASWako AFP-L3 | 04987481164390 | FUJIFILM Wako Pure Chemical Corporation | Class C | |
UDI Compass