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Sign in to claim this brandRoche Diagnostics Corp.
US
Last updated May 23, 2026
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Catalogue (1711)
Page 12 of 35| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| cobas b 123 Sensor Cartridge BG | 05170397001 | FDA UDI | Class II | Unknown |
| Albumin Gen2 | 5166861190 | FDA UDI | Class II | Active |
| PreciControl ClinChem Multi 2 | 5947774160 | FDA UDI | Class I | Active |
| Elecsys T3 | 11731360122 | FDA UDI | Class II | Active |
| Elecsys HSV-1 IgG | 08948852190 | FDA UDI | Class II | Active |
| ONLINE TDM Procainamide | 08252661190 | FDA UDI | Class II | Active |
| Elecsys Toxo IgM | 07028024190 | FDA UDI | Class II | Active |
| Elecsys Troponin I CalCheck 5 | 5931550160 | FDA UDI | Class I | Active |
| Elecsys Testosterone II | 08946353190 | FDA UDI | Class I | Active |
| Elecsys Folate RBC Hemolyzing Reagent | 5944317160 | FDA UDI | Class II | Active |
| Precinorm U plus | 12149435160 | FDA UDI | Class I | Active |
| Quinidine | 4490991190 | FDA UDI | Class II | Active |
| Elecsys IGFBP-3 | 07574690190 | FDA UDI | Class I | Active |
| Vancomycin ONLINE TDM Vancomycin | 4642490190 | FDA UDI | Class II | Unknown |
| navify® Lab Operations | 10382716001 | FDA UDI | Class I | Active |
| Elecsys total PSA | 08791716160 | FDA UDI | Class III | Active |
| Rheumatoid Factors II | 08058628190 | FDA UDI | Class II | Active |
| PrecinormPrecipath Fructosamine | 11098985122 | FDA UDI | Class II | Active |
| Precipath U plus | 12149443160 | FDA UDI | Class I | Active |
| Elecsys HIV combi PT | 05390095160 | FDA UDI | Class II | Active |
| Elecsys IGF-1 | 07475896190 | FDA UDI | Class I | Active |
| total PSA CalCheck | 11776762160 | FDA UDI | Class I | Unknown |
| ONLINE TDM Carbamazepine Gen4 | 7258062190 | FDA UDI | Class II | Active |
| Theophylline | 20737917322 | FDA UDI | Class II | Active |
| PreciControl Phospho-Tau (181P) | 07357052190 | FDA UDI | Class I | Active |
| Elecsys AFP | 09015124190 | FDA UDI | Class II | Active |
| Elecsys ProBNP II | 09744959190 | FDA UDI | Class II | Active |
| Creatinine plus ver2 | 3263991190 | FDA UDI | Class II | Active |
| Elecsys hGH | 5390125190 | FDA UDI | Class I | Active |
| Calcium Gen2 | 5061504190 | FDA UDI | Class II | Active |
| cobas pro i 601 BL | 10271612001 | FDA UDI | Class I | Active |
| Cystatin C Control Set Gen.2 | 6729371190 | FDA UDI | Class I | Active |
| Elecsys FT4 IV | 09043284190 | FDA UDI | Class II | Active |
| Alanine Aminotransferase acc. to IFCC II | 08104697190 | FDA UDI | Class I | Active |
| Tinaquant IgA Gen2 | 3507343190 | FDA UDI | Class II | Active |
| cobas b 123 <3> POC system | 5122279001 | FDA UDI | Class II | Active |
| Tina-quant Digoxin | 12218623001 | FDA UDI | Class II | Unknown |
| Elecsys CKMB STAT CalSet | 5957656190 | FDA UDI | Class II | Active |
| Ammonia II | 07236450190 | FDA UDI | Class I | Active |
| Elecsys Digoxin CalCheck 5 | 5917999160 | FDA UDI | Class I | Active |
| Cardiac C-Reactive Protein (Latex) High Sensitive | 08057605190 | FDA UDI | Class II | Active |
| Creatinine Jaff method | 11929941216 | FDA UDI | Class II | Active |
| Creatine Kinase liquid, acc. to IFCC | 12132672216 | FDA UDI | Class II | Active |
| Vancomycin ONLINE TDM Vancomycin | 4642481190 | FDA UDI | Class II | Unknown |
| Tina-quant Hemoglobin A1cDx Gen.2 Whole blood Application | 04528123160 | FDA UDI | Class II | Active |
| Elecsys CA 15-3 II CalCheck 5 | 6343422160 | FDA UDI | Class I | Active |
| Tina-quant Ferritin Gen.4 | 08057648190 | FDA UDI | Class II | Active |
| Creatine Kinase liquid, acc. to IFCC | 4580591190 | FDA UDI | Class II | Active |
| Elecsys Anti-SARS-CoV 2 | 09203079190 | FDA UDI | Class II | Active |
| Calibrator for automated systems USA standardized | 10759350360 | FDA UDI | Class II | Active |
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