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Mostly Microbiology and Drug Tests, and Laboratory Chemistry and Blood Tests.
| Product | Model | Device type |
|---|---|---|
| Alinity mHepatitis C virus nucleic acid IVD, calibrator | 08N50-075 | Hepatitis C virus nucleic acid IVD, calibrator |
| Alinity mMultiple-type sexually transmitted pathogen nucleic acid IVD, control | 09N17-085 | Multiple-type sexually transmitted pathogen nucleic acid IVD, control |
| Alinity mHuman papillomavirus (HPV) high-risk strain nucleic acid IVD, control | 09N15-085 | Human papillomavirus (HPV) high-risk strain nucleic acid IVD, control |
| Alinity mAssay container IVD, single-use | 09N20-012 | Assay container IVD, single-use |
| Alinity mLaboratory instrument/analyser application software IVD | 09N61-03A | Laboratory instrument/analyser application software IVD |
| Alinity mBK virus (BKV) nucleic acid IVD, control | 09N85-085 | BK virus (BKV) nucleic acid IVD, control |
| Alinity mLaboratory instrument/analyser application software IVD | 09R06-05A | Laboratory instrument/analyser application software IVD |
| Alinity mMpox virus nucleic acid IVD, reagent | 09R06-085 | Mpox virus nucleic acid IVD, reagent |
| Alinity mLaboratory instrument/analyser application software IVD | 09N85-05A | Laboratory instrument/analyser application software IVD |
| Alinity mLaboratory instrument/analyser application software IVD | 09N43-05B | Laboratory instrument/analyser application software IVD |
| Multi-CollectGeneral specimen container IVD, no additive/medium | 9K12-04 | General specimen container IVD, no additive/medium |
| PathVysionHuman epidermal growth factor receptor 2 (HER2) protein IVD, reagent | 02J01-035 | Human epidermal growth factor receptor 2 (HER2) protein IVD, reagent |
| PathVysionHuman epidermal growth factor receptor 2 (HER2) protein IVD, control | 02J04-030 | Human epidermal growth factor receptor 2 (HER2) protein IVD, control |
| RealTimeHepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) | 1N30-90 | Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) |
| RealTimeLaboratory instrument/analyser application software IVD | 08L21-01 | Laboratory instrument/analyser application software IVD |
| RealTimeHepatitis C virus genotyping IVD, control | 08L21-80 | Hepatitis C virus genotyping IVD, control |
| RealTimeDNA anti-contamination enzyme reagent IVD | 08L21-66 | DNA anti-contamination enzyme reagent IVD |
| RealTimeZika virus nucleic acid IVD, control | 09N27-080 | Zika virus nucleic acid IVD, control |
| RealTimeZika virus nucleic acid IVD, reagent | 09N27-090 | Zika virus nucleic acid IVD, reagent |
| RealTimeIsocitrate dehydrogenase 2 (IDH2) gene mutation IVD, kit, nucleic acid technique (NAT) | 08N82-090 | Isocitrate dehydrogenase 2 (IDH2) gene mutation IVD, kit, nucleic acid technique (NAT) |
| RealTimeLaboratory instrument/analyser application software IVD | 09N27-002 | Laboratory instrument/analyser application software IVD |
| RealTimeSARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) | 09N77-095 | SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) |
| simpli-COLLECTGeneral specimen container IVD, no additive/medium | 09R02-001 | General specimen container IVD, no additive/medium |
| simpli-COLLECTGeneral specimen container IVD, no additive/medium | 09N93-001 | General specimen container IVD, no additive/medium |
| UroVysionBladder tumour-associated mutation IVD, probe | 02J27-095 | Bladder tumour-associated mutation IVD, probe |