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| Product | Model | Company | Device type |
|---|---|---|---|
| AccuDiag ™Diagnostic Automation, Inc.Digoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) | DACD1669-15 | Diagnostic Automation, Inc. | Digoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) |
| AccuSign® Nicotine cardPrinceton Biomeditech CorporationCotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) | DOA-217-35-00 | Princeton Biomeditech Corporation | Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) |
| CEDIA Amphetamines/Ecstasy AssayMicrogenics CorporationAmphetamine-specific IVD, kit, enzyme immunoassay (EIA) | 100103 | Microgenics Corporation | Amphetamine-specific IVD, kit, enzyme immunoassay (EIA) |
| CEDIA Digitoxin AssayMicrogenics CorporationDigitoxin therapeutic drug monitoring IVD, kit, fluorescent immunoassay | 100004 | Microgenics Corporation | Digitoxin therapeutic drug monitoring IVD, kit, fluorescent immunoassay |
| Cotinine (COT) Rapid Test CassetteHangzhou AllTest Biotech Co., Ltd.Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) | DCT-102 | Hangzhou AllTest Biotech Co., Ltd. | Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) |
| Dimension Vista® Flex® reagent cartridge DGTXSiemens Healthcare Diagnostics Inc.Digitoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) | 10482947 | Siemens Healthcare Diagnostics Inc. | Digitoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) |
| Dimension® Flex® reagent cartridge DGTXSiemens Healthcare Diagnostics Inc.Digitoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) | 10444932 | Siemens Healthcare Diagnostics Inc. | Digitoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) |
| DRI Acetaminophen Serum Tox AssayMicrogenics CorporationAcetaminophen IVD, kit, enzyme immunoassay (EIA) | 1086 | Microgenics Corporation | Acetaminophen IVD, kit, enzyme immunoassay (EIA) |
| Emit® 2000 Digoxin AssaySiemens Healthcare Diagnostics Inc.Digoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) | 10445317 | Siemens Healthcare Diagnostics Inc. | Digoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) |
| Emit® 2000 Gentamicin Plus AssaySiemens Healthcare Diagnostics Inc.Gentamicin therapeutic drug monitoring IVD, calibrator | 10445335 | Siemens Healthcare Diagnostics Inc. | Gentamicin therapeutic drug monitoring IVD, calibrator |
| INSTANT-VIEW Propoxyphene (PPX) Urine Cassette TestAlfa Scientific Designs, Inc.Propoxyphene IVD, kit, enzyme immunoassay (EIA) | 03-2932 | Alfa Scientific Designs, Inc. | Propoxyphene IVD, kit, enzyme immunoassay (EIA) |
| Myoglobin Enzyme Immunoassay Test KitBiomerica, Inc.Myoglobin IVD, kit, enzyme immunoassay (EIA) | 7030 | Biomerica, Inc. | Myoglobin IVD, kit, enzyme immunoassay (EIA) |
| ONLINE TDM AmikacinRoche Diagnostics GmbHAmikacin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry | 08105383190 | Roche Diagnostics GmbH | Amikacin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry |
| ONLINE TDM ProcainamideRoche Diagnostics GmbHProcainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) | 08252661190 | Roche Diagnostics GmbH | Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) |
| ONLINE TDM Vancomycin Gen.3Roche Diagnostics GmbHVancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry | 08445605190 | Roche Diagnostics GmbH | Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry |
| Pointe Scientific, Inc.Horiba Instruments IncorporatedMyoglobin IVD, kit, enzyme immunoassay (EIA) | CM1117-96 | Horiba Instruments Incorporated | Myoglobin IVD, kit, enzyme immunoassay (EIA) |
| SynchronBeckman Coulter, Inc.Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) | 469137 | Beckman Coulter, Inc. | Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) |
| Syva® Emit® 2000 Digoxin AssaySiemens Healthcare Diagnostics Inc.Digoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) | 10445315 | Siemens Healthcare Diagnostics Inc. | Digoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) |
| Syva® Emit® 2000 Phenytoin AssaySiemens Healthcare Diagnostics Inc.Phenytoin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) | 10445303 | Siemens Healthcare Diagnostics Inc. | Phenytoin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) |
| Syva® Emit® 2000 Procainamide CalibratorsSiemens Healthcare Diagnostics Inc.Procainamide therapeutic drug monitoring IVD, calibrator | 10445319 | Siemens Healthcare Diagnostics Inc. | Procainamide therapeutic drug monitoring IVD, calibrator |
| Syva® Emit® 2000 Qunidine AssaySiemens Healthcare Diagnostics Inc.Quinidine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) | 10445327 | Siemens Healthcare Diagnostics Inc. | Quinidine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) |
| Syva® Emit® Amikacin AssaySiemens Healthcare Diagnostics Inc.Amikacin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) | 10445383 | Siemens Healthcare Diagnostics Inc. | Amikacin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) |
| TobramycinRoche Diagnostics GmbHTobramycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) | 4491033190 | Roche Diagnostics GmbH | Tobramycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) |
| Valproic AcidRoche Diagnostics GmbHValproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) | 5108438190 | Roche Diagnostics GmbH | Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) |
| VITROSOrtho-Clinical Diagnostics, Inc.Digoxin therapeutic drug monitoring IVD, reagent | 8343386 | Ortho-Clinical Diagnostics, Inc. | Digoxin therapeutic drug monitoring IVD, reagent |