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| BioPlexBio-Rad Laboratories, Inc.Treponema pallidum total antibody IVD, kit, fluorescent immunoassay | SW4.3 v5.0 | Bio-Rad Laboratories, Inc. | Treponema pallidum total antibody IVD, kit, fluorescent immunoassay |
| Trinity BiotechMardx Diagnostics, Inc.Borrelia burgdorferi total antibody IVD, kit, fluorescent immunoassay | 40-2017 | Mardx Diagnostics, Inc. | Borrelia burgdorferi total antibody IVD, kit, fluorescent immunoassay |
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