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| Product | Model | Company | Device type |
|---|---|---|---|
| P KDY Pack 4 WELLScimedx CorporationGlomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassay | 5601 | Scimedx Corporation | Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassay |
| PCA(RS)48 Test(L)Scimedx CorporationIntrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay | 4048L | Scimedx Corporation | Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay |
| PCA(RS)96 Test(L)Scimedx CorporationIntrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay | 4096L | Scimedx Corporation | Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay |
| QUANTA Flash® M2 (MIT3) ReagentsInova Diagnostics, Inc.Mitochondrial antibody M2 (anti-Mi2) IVD, kit, chemiluminescent immunoassay | 701303 | Inova Diagnostics, Inc. | Mitochondrial antibody M2 (anti-Mi2) IVD, kit, chemiluminescent immunoassay |
| SMA(MsS)96 Test(L)Scimedx CorporationSmooth muscle antibody IVD, kit, fluorescent immunoassay | 31096L | Scimedx Corporation | Smooth muscle antibody IVD, kit, fluorescent immunoassay |
| SMA(RS) 96 Test(L)Scimedx CorporationSmooth muscle antibody IVD, kit, fluorescent immunoassay | 3096L | Scimedx Corporation | Smooth muscle antibody IVD, kit, fluorescent immunoassay |
| Trinity BiotechMardx Diagnostics, Inc.Multiple cardiac marker IVD, kit, fluorescent immunoassay | 10-5408 | Mardx Diagnostics, Inc. | Multiple cardiac marker IVD, kit, fluorescent immunoassay |
| Trinity BiotechMardx Diagnostics, Inc.Skeletal muscle antibody IVD, kit, fluorescent immunoassay | 10-5848 | Mardx Diagnostics, Inc. | Skeletal muscle antibody IVD, kit, fluorescent immunoassay |
| Trinity BiotechMardx Diagnostics, Inc.Skeletal muscle antibody IVD, kit, fluorescent immunoassay | 10-5804 | Mardx Diagnostics, Inc. | Skeletal muscle antibody IVD, kit, fluorescent immunoassay |
| Trinity BiotechMardx Diagnostics, Inc.Skeletal muscle antibody IVD, kit, fluorescent immunoassay | 10-5808 | Mardx Diagnostics, Inc. | Skeletal muscle antibody IVD, kit, fluorescent immunoassay |
| uTASWako AFP-L3 Sample Dilution BufferFujifilm Wako Pure Chemical CorporationAlpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassay | 997-61501 | Fujifilm Wako Pure Chemical Corporation | Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassay |