| Access GI Monitor | 15099590817060 | Beckman Coulter Inc. | Class C | |
| Access GI Monitor (Reagent Pack) | 15099590231842 | Beckman Coulter Inc. | Class C | |
| ADVIA Centaur® CA 19-9™ | 00630414574028 | Siemens Healthcare Diagnostics Inc. | Class C | |
| ADVIA Centaur® CA 19-9™ | 00630414574257 | Siemens Healthcare Diagnostics Inc. | Class C | |
| AFIAS CA19-9 | 08806133006399 | Boditech Med Inc. | Unknown class | |
| AFIAS CA19-9 | 08806133043875 | Boditech Med Inc. | Class C | |
| AIA-PACK SLa CALIBRATOR SET | 04560189212053 | Tosoh Corporation | Unknown class | |
| AIA-PACK SLa SAMPLE DILUTING SOLUTION | 04560189212060 | Tosoh Corporation | Unknown class | |
| Alinity | 00380740130527 | ABBOTT GmbH | Class C | |
| Alinity | 00380740130534 | ABBOTT GmbH | Class C | |
| Alinity | 00380740165574 | ABBOTT GmbH | Class C | |
| Alinity | 00380740165581 | ABBOTT GmbH | Class C | |
| ARCHITECT | 00380740137151 | ABBOTT GmbH | Class C | |
| ARCHITECT | 00380740137168 | ABBOTT GmbH | Class C | |
| ARCHITECT | 00380740137175 | ABBOTT GmbH | Class C | |
| ARCHITECT | 00380740166403 | ABBOTT GmbH | Class C | |
| ARCHITECT | 00380740166410 | ABBOTT GmbH | Class C | |
| ARCHITECT | 00380740166427 | ABBOTT GmbH | Class C | |
| Atellica IM CA 19-9 (CA19-9) | 00630414598161 | Siemens Healthcare Diagnostics Inc. | Class C | |
| Atellica IM CA 19-9 (CA19-9) | 00630414598178 | Siemens Healthcare Diagnostics Inc. | Class C | |
| AURYX 90 CA 19-9 Reagent Kit | 05907514600489 | PZ CORMAY Spółka Akcyjna | Unknown class | |
| AURYX 90 CA19-9 Reagent Kit | 05907514600472 | PZ CORMAY Spółka Akcyjna | Unknown class | |
| B·R·A·H·M·S CA 19-9 KRYPTOR | 04260157631878 | B·R·A·H·M·S GmbH | Class C | |
| CA 19-9 AccuBind ELISA Kit - 192 wells | 00816870020525 | Monobind Inc. | Unknown class | |
| CA 19-9 AccuBind ELISA Kit - 96 wells | 00816870020518 | Monobind Inc. | Class C | |
| CA 19-9 AccuLite CLIA Kit - 192 wells | 00816870022208 | Monobind Inc. | Unknown class | |
| CA 19-9 AccuLite CLIA Kit - 96 wells | 00816870022192 | Monobind Inc. | Class C | |
| CA 19-9 Assay (CLIA) | 06941967231066 | Zybio Inc. | Unknown class | |
| CA19-9 Assay Kit (Fluorescence Immunoassay) | 06975424223387 | DiYaLab ZJG Biotech Co., Ltd | Unknown class | |
| CA19-9 Assay Kit (Fluorescence Immunoassay) | 06975424225831 | DiYaLab ZJG Biotech Co., Ltd | Unknown class | |
| CA19-9 CLIA | 06942609200280 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA19-9 CLIA | 06942609200297 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA19-9 CLIA | 06942609200303 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA19-9 CLIA | 06942609200310 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA19-9 CLIA | 06942609202956 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA19-9 CLIA | 06942609202963 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA19-9 CLIA | 06942609202970 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA19-9 CLIA | 06942609202987 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA19-9 CLIA Microparticles | 06942359516860 | Autobio Diagnostics Co., Ltd. | Class C | |
| CA19-9 CLIA Microparticles | 06942359549592 | Autobio Diagnostics Co., Ltd. | Class C | |
| CA19-9 CLIA Microparticles | 06942359549615 | Autobio Diagnostics Co., Ltd. | Class C | |
| CA19-9 CLIA Microparticles | 06970150908348 | Autobio Diagnostics Co., Ltd. | Class C | |
| CA19-9 Fast Test Kit (Immunofluorescence Assay) | 06954414702682 | Getein Biotech, Inc. | Unknown class | |
| CA19-9 FIA Kit | 06974674892138 | Shenzhen Zijian Biotechnology Co., Ltd | Unknown class | |
| CA19-9 Immunofluorescence Assay | 06942609216908 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA19-9 Immunofluorescence Assay | 06942609216915 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA19-9 Immunofluorescence Assay | 06942609216922 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA19-9 Immunofluorescence Assay | 06942609216939 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA19-9 Immunofluorescence Assay | 06942609216946 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
| CA19-9 Immunofluorescence Assay | 06942609216953 | Guangzhou KOFA Biotechnology Co., Ltd. | Unknown class | |
UDI Compass