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| Product | Model | Company | Device type |
|---|---|---|---|
| Bio-RadClark Laboratories, Inc.Multiple Plasmodium species total antibody IVD, kit, enzyme immunoassay (EIA) | 72526 | Clark Laboratories, Inc. | Multiple Plasmodium species total antibody IVD, kit, enzyme immunoassay (EIA) |
| MycoMEIA Aspergillus Assay Sample Processing ColumnsPearl DiagnosticsMultiple Aspergillus species antigen IVD, kit, enzyme immunoassay (EIA) | 25102 | Pearl Diagnostics | Multiple Aspergillus species antigen IVD, kit, enzyme immunoassay (EIA) |
| MycoMEIA Aspergillus Assay Uncoated PlatesPearl DiagnosticsMultiple Aspergillus species antigen IVD, kit, enzyme immunoassay (EIA) | 25101 | Pearl Diagnostics | Multiple Aspergillus species antigen IVD, kit, enzyme immunoassay (EIA) |
| PlateliaBio-RadMultiple Aspergillus species antigen IVD, kit, enzyme immunoassay (EIA) | 12014064 | Bio-Rad | Multiple Aspergillus species antigen IVD, kit, enzyme immunoassay (EIA) |
| RSV IgG 120 Test KitScimedx CorporationRespiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay | I-RSV01G | Scimedx Corporation | Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay |
| SofiaQuidel Cardiovascular Inc.Multiple Campylobacter species antibody IVD, kit, fluorescent immunoassay | 20352 | Quidel Cardiovascular Inc. | Multiple Campylobacter species antibody IVD, kit, fluorescent immunoassay |
| Trinity BiotechClark Laboratories, Inc.Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | 2325200 | Clark Laboratories, Inc. | Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) |
| Trinity BiotechClark Laboratories, Inc.Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | 2325900 | Clark Laboratories, Inc. | Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) |
| Trinity BiotechClark Laboratories, Inc.Multiple Chlamydia species immunoglobulin G (IgG) antibody IVD, reagent | 2346200 | Clark Laboratories, Inc. | Multiple Chlamydia species immunoglobulin G (IgG) antibody IVD, reagent |
| Trinity BiotechClark Laboratories, Inc.Multiple Plasmodium species total antibody IVD, kit, enzyme immunoassay (EIA) | 2322470 | Clark Laboratories, Inc. | Multiple Plasmodium species total antibody IVD, kit, enzyme immunoassay (EIA) |
| Trinity BiotechClark Laboratories, Inc.Multiple Plasmodium species total antibody IVD, kit, enzyme immunoassay (EIA) | 2322471 | Clark Laboratories, Inc. | Multiple Plasmodium species total antibody IVD, kit, enzyme immunoassay (EIA) |
| Trinity BiotechMardx Diagnostics, Inc.Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA) | 1206611 | Mardx Diagnostics, Inc. | Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA) |
| Trinity BiotechClark Laboratories, Inc.Chromogenic/colorimetric substrate reagent IVD | 525700 | Clark Laboratories, Inc. | Chromogenic/colorimetric substrate reagent IVD |
| Trinity BiotechClark Laboratories, Inc.Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | 2325201 | Clark Laboratories, Inc. | Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) |
| Trinity BiotechClark Laboratories, Inc.Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | 2325601 | Clark Laboratories, Inc. | Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) |
| Trinity BiotechClark Laboratories, Inc.Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | 2346401 | Clark Laboratories, Inc. | Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) |
| Trinity BiotechMardx Diagnostics, Inc.Trypanosoma cruzi total antibody IVD, kit, fluorescent immunoassay | 20-03648 | Mardx Diagnostics, Inc. | Trypanosoma cruzi total antibody IVD, kit, fluorescent immunoassay |
| Trinity BiotechMardx Diagnostics, Inc.Trypanosoma cruzi total antibody IVD, kit, fluorescent immunoassay | 20-03006 | Mardx Diagnostics, Inc. | Trypanosoma cruzi total antibody IVD, kit, fluorescent immunoassay |
| Trinity BiotechMardx Diagnostics, Inc.Trypanosoma cruzi total antibody IVD, kit, fluorescent immunoassay | 20-03012 | Mardx Diagnostics, Inc. | Trypanosoma cruzi total antibody IVD, kit, fluorescent immunoassay |
| Trinity BiotechMardx Diagnostics, Inc.Multiple Leishmania species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay | 20-04006 | Mardx Diagnostics, Inc. | Multiple Leishmania species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay |