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| Product | Model | Company | Device type |
|---|---|---|---|
| 4Kscore TestBioreference Health, LLCBlood collection set, noninvasive | 1 | Bioreference Health, LLC | Blood collection set, noninvasive |
| Access AFPBeckman Coulter, Inc.Trisomy 21-risk hormone IVD, kit, chemiluminescent immunoassay | C28649 | Beckman Coulter, Inc. | Trisomy 21-risk hormone IVD, kit, chemiluminescent immunoassay |
| Access Hybritech p2PSABeckman Coulter, Inc.Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay | B03704 | Beckman Coulter, Inc. | Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay |
| Access Hybritech p2PSA CalibratorsBeckman Coulter, Inc.Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay | B03705 | Beckman Coulter, Inc. | Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay |
| ADVIA CENTAUR ELF KITSiemens Healthcare Diagnostics Inc.Multiple liver fibrosis marker IVD, kit, chemiluminescent immunoassay | 11207300 | Siemens Healthcare Diagnostics Inc. | Multiple liver fibrosis marker IVD, kit, chemiluminescent immunoassay |
| ADVIA Centaur® CA 15-3® MCMSiemens Healthcare Diagnostics Inc.Cancer antigen 15-3 (CA15-3) IVD, control | 10330854 | Siemens Healthcare Diagnostics Inc. | Cancer antigen 15-3 (CA15-3) IVD, control |
| ADVIA Centaur® PSASiemens Healthcare Diagnostics Inc.Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay | 10310293 | Siemens Healthcare Diagnostics Inc. | Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay |
| ADVIA Centaur® Systems, ACS 180® Systems cPSA MCMSiemens Healthcare Diagnostics Inc.Complexed prostate specific antigen (cPSA) IVD, control | 10310380 | Siemens Healthcare Diagnostics Inc. | Complexed prostate specific antigen (cPSA) IVD, control |
| ADVIA Centaur® Systems, ACS:180® Systems Calibrator DSiemens Healthcare Diagnostics Inc.Multiple tissue-associated protein/tumour marker IVD, calibrator | 10311576 | Siemens Healthcare Diagnostics Inc. | Multiple tissue-associated protein/tumour marker IVD, calibrator |
| AlinityAbbott Ireland DiagnosticsAlpha-fetoprotein (AFP) IVD, calibrator | 07P9001 | Abbott Ireland Diagnostics | Alpha-fetoprotein (AFP) IVD, calibrator |
| AlinityAbbott Ireland DiagnosticsTotal prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay | 07P9221 | Abbott Ireland Diagnostics | Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay |
| Atellica IM AFPSiemens Healthcare Diagnostics Inc.Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay | 11202257 | Siemens Healthcare Diagnostics Inc. | Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay |
| Atellica IM Calibrator DSiemens Healthcare Diagnostics Inc.Multiple tissue-associated protein/tumour marker IVD, calibrator | 10995509 | Siemens Healthcare Diagnostics Inc. | Multiple tissue-associated protein/tumour marker IVD, calibrator |
| Atellica IM Calibrator QSiemens Healthcare Diagnostics Inc.Total prostate specific antigen (tPSA) IVD, calibrator | 10995517 | Siemens Healthcare Diagnostics Inc. | Total prostate specific antigen (tPSA) IVD, calibrator |
| Atellica IM cPSASiemens Healthcare Diagnostics Inc.Complexed prostate specific antigen (cPSA) IVD, kit, chemiluminescent immunoassay | 10995544 | Siemens Healthcare Diagnostics Inc. | Complexed prostate specific antigen (cPSA) IVD, kit, chemiluminescent immunoassay |
| AutoDELFIA hAFP kitWallac OyAlpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay | B079-212 | Wallac Oy | Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay |
| Elecsys AFPRoche Diagnostics GmbHAlpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay | 09015060160 | Roche Diagnostics GmbH | Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay |
| Elecsys AFPRoche Diagnostics GmbHAlpha-fetoprotein (AFP) IVD, calibrator | 09731385190 | Roche Diagnostics GmbH | Alpha-fetoprotein (AFP) IVD, calibrator |
| Elecsys AFP AssayRoche Diagnostics GmbHAlpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay | 4491742160 | Roche Diagnostics GmbH | Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay |
| Elecsys free PSARoche Diagnostics GmbHFree (unbound) prostate specific antigen (fPSA) IVD, control | 03289788160 | Roche Diagnostics GmbH | Free (unbound) prostate specific antigen (fPSA) IVD, control |
| FastPack® IP Vitamin D Kit CompleteQualigen Inc.Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay | Vit. D Immunoassay | Qualigen Inc. | Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay |
| FREND PSA PlusNanoEnTek, Inc.Total prostate specific antigen (tPSA) IVD, kit, fluorescent immunoassay | FRPS 025 | NanoEnTek, Inc. | Total prostate specific antigen (tPSA) IVD, kit, fluorescent immunoassay |
| IsoPSA ControlsCleveland Diagnostics, Inc.Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent | P901 | Cleveland Diagnostics, Inc. | Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent |
| IsoPSA ReagentCleveland Diagnostics, Inc.Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent | P302 | Cleveland Diagnostics, Inc. | Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent |
| ST AIA-PACK PATosoh CorporationTotal prostate specific antigen (tPSA) IVD, kit, fluorescent immunoassay | — | Tosoh Corporation | Total prostate specific antigen (tPSA) IVD, kit, fluorescent immunoassay |