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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 15 of 35| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Elecsys NMID Osteocalcin Immunoassay | 12149133160 | FDA UDI | Class II | Active |
| Elecsys Troponin T | 4491815190 | FDA UDI | Class II | Active |
| Elecsys free PSA | 03289788160 | FDA UDI | Class III | Active |
| PreciControl Growth | 07476108190 | FDA UDI | Class I | Active |
| Elecsys proBNP II CalSet | 09315292190 | FDA UDI | Class II | Active |
| Elecsys Anti-HBs | 11820524160 | FDA UDI | Class II | Active |
| Myoglobin Control Set | 11730835216 | FDA UDI | Class I | Active |
| B-Gate Interface | 06884750001 | FDA UDI | Class I | Active |
| Primidone | 20737887322 | FDA UDI | Class II | Active |
| PreciControl Chagas | 07092571162 | FDA UDI | U | Active |
| Elecsys Insulin | 07027559190 | FDA UDI | Class I | Active |
| Kinetic UV assay for ureaurea nitrogen | 11929488216 | FDA UDI | Class II | Active |
| Valproic Acid | 4491041190 | FDA UDI | Class II | Active |
| Creatine Kinase liquid, acc. to IFCC | 4580613190 | FDA UDI | Class II | Active |
| ONLINE TDM Phenobarbital | 08058580190 | FDA UDI | Class II | Active |
| Elecsys Anti-HCV II | 08837058190 | FDA UDI | Class II | Active |
| Bicarbonate liquid | 3289885190 | FDA UDI | Class II | Active |
| ISE Standard High | 11183982216 | FDA UDI | Class II | Active |
| Total Bilirubin | 11822713216 | FDA UDI | Class II | Unknown |
| cobas b 221 <4> system | 3337138001 | FDA UDI | Class II | Active |
| Elecsys HCG STAT CalCheck 5 | 5579082160 | FDA UDI | Class I | Active |
| Tg II CalCheck 5 | 05918081190 | FDA UDI | Class I | Active |
| Vitamin D total II CalCheck 5 | 07464258190 | FDA UDI | Class I | Active |
| Tina-quant Hemoglobin A1cDx Gen.3 | 08445699190 | FDA UDI | Class II | Active |
| Control Set DAT II | 3312968190 | FDA UDI | Class I | Active |
| Elecsys CMV IgG | 09118551190 | FDA UDI | Class II | Active |
| Tinaquant IgG Gen2 | 3507432190 | FDA UDI | Class II | Active |
| Tinaquant Ferritin Gen4 | 4885627190 | FDA UDI | Class II | Active |
| Lactate Dehydrogenase acc to IFCC ver2 | 3004732122 | FDA UDI | Class II | Active |
| Antistreptolysin O | 20750948322 | FDA UDI | Class I | Active |
| Calibrator for automated systems | 10759350190 | FDA UDI | Class II | Unknown |
| cobas 6000 c501 module | 7790198001 | FDA UDI | Class I | Active |
| navify POC Operations | 10170280001 | FDA UDI | Class I | Active |
| Albumin BCP | 5975573190 | FDA UDI | Class II | Active |
| Elecsys HTLV-I/II | 09015272162 | FDA UDI | U | Active |
| PreciControl HTLV | 07108133162 | FDA UDI | U | Active |
| Elecsys SHBG | 07258496190 | FDA UDI | Class I | Active |
| Myoglobin Gen2 Tinaquant Myoglobin Gen2 | 4579976190 | FDA UDI | Class II | Active |
| Creatinine Jaff method | 11875418216 | FDA UDI | Class II | Active |
| Tinaquant Cardiac Creactive Protein Latex High Sensitive | 11972855216 | FDA UDI | Class II | Active |
| Bilirubin Direct Gen.2 (Doumas standardization) | 05589061190 | FDA UDI | Class II | Active |
| Phosphate (Inorganic) ver.2 | 5171377190 | FDA UDI | Class I | Active |
| cobas infinity POC | 09159053001 | FDA UDI | Class I | Active |
| Elecsys CMV IgG | 09338977160 | FDA UDI | Class II | Active |
| Accu-Chek Inform II Base Unit | 07828411001 | FDA UDI | Class II | Active |
| Unsaturated Iron-Binding Capacity | 4536355190 | FDA UDI | Class I | Active |
| Free Phenytoin Controls | 20759023322 | FDA UDI | Class II | Active |
| Chemstrip 2 LN Test Strips | 11895460160 | FDA UDI | Class I | Active |
| Elecsys Vitamin B12 II | 07212771160 | FDA UDI | Class II | Active |
| ISE Chloride Electrode | 4834909001 | FDA UDI | Class II | Active |
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