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| Product | Model | Company | Device type |
|---|---|---|---|
| ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)Siemens Healthcare Diagnostics Inc.Cytokeratin IVD, kit, chemiluminescent immunoassay | 11354590 | Siemens Healthcare Diagnostics Inc. | Cytokeratin IVD, kit, chemiluminescent immunoassay |
| AlinityAbbott GmbHHuman epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay | 08P5021 | Abbott GmbH | Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay |
| AlinityAbbott GmbHCancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay | 03R7521 | Abbott GmbH | Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay |
| Atellica IM CYFRA 21-1Siemens Healthcare Diagnostics Inc.Cytokeratin IVD, kit, chemiluminescent immunoassay | 11354591 | Siemens Healthcare Diagnostics Inc. | Cytokeratin IVD, kit, chemiluminescent immunoassay |
| B.R.A.H.M.S sFlt-1 KRYPTORB.R.A.H.M.S GmbHSoluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD, kit, fluorescent immunoassay | 845075N | B.R.A.H.M.S GmbH | Soluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD, kit, fluorescent immunoassay |
| CYFRA 21-1 EIAFujirebio Diagnostics ABCytokeratin IVD, kit, chemiluminescent immunoassay | 211-10 | Fujirebio Diagnostics AB | Cytokeratin IVD, kit, chemiluminescent immunoassay |
| DiviTum®TKaBiovica International ABThymidine kinase IVD, kit, enzyme immunoassay (EIA) | 95010 | Biovica International AB | Thymidine kinase IVD, kit, enzyme immunoassay (EIA) |
| Elecsys CYFRA 21-1Roche Diagnostics GmbHCytokeratin IVD, kit, chemiluminescent immunoassay | 11820966160 | Roche Diagnostics GmbH | Cytokeratin IVD, kit, chemiluminescent immunoassay |
| Elecsys HE4Roche Diagnostics GmbHHuman epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay | 07027478190 | Roche Diagnostics GmbH | Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay |
| Elecsys PlGFRoche Diagnostics GmbHSoluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD, kit, chemiluminescent immunoassay | 09015434190 | Roche Diagnostics GmbH | Soluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD, kit, chemiluminescent immunoassay |
| HE4 EIAFujirebio Diagnostics ABHuman epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay | 404-10US | Fujirebio Diagnostics AB | Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay |
| Lumipulse G Mesothelin Immunoreaction CartridgesFujirebio Inc.Soluble mesothelin-related peptide (SMRP) IVD, kit, chemiluminescent immunoassay | 235157 | Fujirebio Inc. | Soluble mesothelin-related peptide (SMRP) IVD, kit, chemiluminescent immunoassay |
| Lumipulse G ROMAFujirebio Diagnostics, Inc.Laboratory instrument/analyser application software IVD | CL0004 | Fujirebio Diagnostics, Inc. | Laboratory instrument/analyser application software IVD |
| OVA1Aspira Women's Health Inc.Medical equipment clinical data interfacing software | 3.0.3.006 | Aspira Women's Health Inc. | Medical equipment clinical data interfacing software |
| OveraAspira Women's Health Inc.Medical equipment clinical data interfacing software | 4.0.0 | Aspira Women's Health Inc. | Medical equipment clinical data interfacing software |
| ROMAFujirebio Diagnostics, Inc.Laboratory instrument/analyser application software IVD | 404-10US | Fujirebio Diagnostics, Inc. | Laboratory instrument/analyser application software IVD |