| Access BR Monitor | 15099590817046 | Beckman Coulter Inc. | Class C | |
| Access BR Monitor (Reagent Pack) | 15099590231859 | Beckman Coulter Inc. | Class C | |
| ADVIA Centaur® CA 15-3® | 00630414461311 | Siemens Healthcare Diagnostics Inc. | Class C | |
| ADVIA Centaur® CA 15-3® | 00630414461328 | Siemens Healthcare Diagnostics Inc. | Class C | |
| AIA-PACK 27.29 CALIBRATOR SET | 04560189211858 | Tosoh Corporation | Unknown class | |
| AIA-PACK 27.29 SAMPLE DILUTING SOLUTION | 04560189211865 | Tosoh Corporation | Unknown class | |
| Alinity | 00380740131432 | ABBOTT GmbH | Class C | |
| Alinity | 00380740131449 | ABBOTT GmbH | Class C | |
| Alinity | 00380740165604 | ABBOTT GmbH | Class C | |
| Alinity | 00380740165611 | ABBOTT GmbH | Class C | |
| ARCHITECT | 00380740145316 | ABBOTT GmbH | Class C | |
| ARCHITECT | 00380740145323 | ABBOTT GmbH | Class C | |
| ARCHITECT | 00380740145330 | ABBOTT GmbH | Class C | |
| ARCHITECT | 00380740166366 | ABBOTT GmbH | Class C | |
| ARCHITECT | 00380740166373 | ABBOTT GmbH | Class C | |
| ARCHITECT | 00380740166380 | ABBOTT GmbH | Class C | |
| Atellica IM CA 15-3 (CA15-3) | 00630414598123 | Siemens Healthcare Diagnostics Inc. | Class C | |
| Atellica IM CA 15-3 (CA15-3) | 00630414598130 | Siemens Healthcare Diagnostics Inc. | Class C | |
| AURYX 90 CA 15-3 Reagent Kit | 05907514600434 | PZ CORMAY Spółka Akcyjna | Unknown class | |
| AURYX 90 CA 15-3 Reagent Kit | 05907514600441 | PZ CORMAY Spółka Akcyjna | Unknown class | |
| B·R·A·H·M·S CA 15-3 KRYPTOR | 04260157631885 | B·R·A·H·M·S GmbH | Class C | |
| CA 15-3 AccuBind ELISA Kit - 192 wells | 00816870020495 | Monobind Inc. | Class C | |
| CA 15-3 AccuLite CLIA Kit - 192 wells | 00816870020501 | Monobind Inc. | Unknown class | |
| CA 15-3 AccuLite CLIA Kit - 192 wells | 00816870022185 | Monobind Inc. | Unknown class | |
| CA 15-3 AccuLite CLIA Kit - 96 wells | 00816870022178 | Monobind Inc. | Unknown class | |
| CA 15-3 Assay (CLIA) | 06941967231103 | Zybio Inc. | Unknown class | |
| CA15-3 CLIA | 06942609200242 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA15-3 CLIA | 06942609200259 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA15-3 CLIA | 06942609200266 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA15-3 CLIA | 06942609200273 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA15-3 CLIA | 06942609202918 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA15-3 CLIA | 06942609202925 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA15-3 CLIA | 06942609202932 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA15-3 CLIA | 06942609202949 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA15-3 CLIA Microparticles | 06942359549295 | Autobio Diagnostics Co., Ltd. | Class C | |
| CA15-3 CLIA Microparticles | 06942359549318 | Autobio Diagnostics Co., Ltd. | Class C | |
| CA15-3 CLIA Microparticles | 06970150908331 | Autobio Diagnostics Co., Ltd. | Class C | |
| CA15-3 Fast Test Kit (Immunofluorescence Assay) | 06954414702699 | Getein Biotech, Inc. | Unknown class | |
| CA15-3 FIA Kit | 06974674892152 | Shenzhen Zijian Biotechnology Co., Ltd | Unknown class | |
| CA15-3 Immunofluorescence Assay | 06942609216830 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA15-3 Immunofluorescence Assay | 06942609216847 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA15-3 Immunofluorescence Assay | 06942609216854 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA15-3 Immunofluorescence Assay | 06942609216861 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA15-3 Immunofluorescence Assay | 06942609216878 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA15-3 Immunofluorescence Assay | 06942609216885 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA15-3 Kit (CLIA) | 06936595751253 | MedicalSystem Biotechnology Co., Ltd. | Unknown class | |
| CA15-3 Rapid Quantitative Test (Chemiluminescence Immunoassay) | 06933260207329 | Xiamen Biotime Biotechnology Co., Ltd. | Unknown class | |
| CA15-3 Rapid Quantitative Test (Chemiluminescence Immunoassay) | 06933260207336 | Xiamen Biotime Biotechnology Co., Ltd. | Unknown class | |
| CA15-3 Rapid Quantitative Test (Chemiluminescence Immunoassay) | 06933260207343 | Xiamen Biotime Biotechnology Co., Ltd. | Unknown class | |
| CA15-3 Rapid Quantitative Test (Chemiluminescence Immunoassay) | 06933260207350 | Xiamen Biotime Biotechnology Co., Ltd. | Unknown class | |
UDI Compass