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| Product | Model | Company | Device type |
|---|---|---|---|
| ST AIA-PACK PATosoh CorporationTotal prostate specific antigen (tPSA) IVD, kit, fluorescent immunoassay | — | Tosoh Corporation | Total prostate specific antigen (tPSA) IVD, kit, fluorescent immunoassay |
| SynchronBeckman Coulter, Inc.Methaqualone IVD, reagent | 475021 | Beckman Coulter, Inc. | Methaqualone IVD, reagent |
| TheophyllineRoche Diagnostics GmbHTheophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry | 4491025190 | Roche Diagnostics GmbH | Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry |
| VITROSOrtho-Clinical Diagnostics, Inc.Carbamazepine therapeutic drug monitoring IVD, reagent | 8892382 | Ortho-Clinical Diagnostics, Inc. | Carbamazepine therapeutic drug monitoring IVD, reagent |
| VITROSOrtho-Clinical Diagnostics, Inc.Theophylline therapeutic drug monitoring IVD, reagent | 1307164 | Ortho-Clinical Diagnostics, Inc. | Theophylline therapeutic drug monitoring IVD, reagent |