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Mostly Microbiology and Drug Tests, and Laboratory Chemistry and Blood Tests.
| Product | Model | Device type |
|---|---|---|
| ViroSeqLaboratory instrument/analyser application software IVD | 4J94-23 | Laboratory instrument/analyser application software IVD |
| VP2000Nucleic acid hybridization detection IVD, reagent | 08N16-001 | Nucleic acid hybridization detection IVD, reagent |
| VysisHuman epidermal growth factor receptor 2 (HER2) protein IVD, control | 02J04-010 | Human epidermal growth factor receptor 2 (HER2) protein IVD, control |
| VysisChronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe | 04N02-020 | Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe |
| VysisAcute myeloid leukaemia (AML) genetic mutation IVD, probe | 04N37-020 | Acute myeloid leukaemia (AML) genetic mutation IVD, probe |
| VysisMultiple congenital aneuploidy screening IVD, probe | 05J38-030 | Multiple congenital aneuploidy screening IVD, probe |
| VysisAnaplastic lymphoma kinase (ALK) genetic mutation IVD, control | 06N38-005 | Anaplastic lymphoma kinase (ALK) genetic mutation IVD, control |
| VysisCancer/tumour-associated aneuploidy IVD, probe | 07J21-001 | Cancer/tumour-associated aneuploidy IVD, probe |
| VysisChronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe | 07J22-012 | Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe |