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Sign in to claim this brandRoche Diagnostics Corp.
US
Last updated May 23, 2026
What Roche Diagnostics Corp. makes
Roche Diagnostics Corp. manufactures in vitro diagnostic (IVD) devices for clinical chemistry, including analyte profile controls and calibrators, as well as standalone tests for substances like total bilirubin, magnesium, human chorionic gonadotropin, and parathyroid hormone. Their portfolio also includes rapid urine analyte tests, chemiluminescent immunoassays, and nephelometric/turbidimetric assays for proteins such as transferrin. Point-of-care (POC) and remote-access testing systems, as well as troponin, myoglobin, and thyroid-stimulating hormone assays, are also part of their offerings.
The company’s devices are regulated under FDA’s classification system, spanning Class I, Class II, Class III, and unclassified (U) categories. These products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. regulatory requirements. Roche Diagnostics Corp. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
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Catalogue (1711)
Page 1 of 35| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Elecsys Troponin T Gen 5 STAT | 07398000160 | FDA UDI | Class II | Active |
| Sodium Electrode | 21029371001 | FDA UDI | Class II | Active |
| ONLINE TDM Carbamazepine Gen.4 | 08057435190 | FDA UDI | Class II | Active |
| Triglycerides | 05171407190 | FDA UDI | Class I | Active |
| Tina-quant Myoglobin Gen.2 | 08252629190 | FDA UDI | Class II | Active |
| cobas infinity POC remote access | 09220763001 | FDA UDI | Class I | Active |
| total PSA CalSet II | 08838534160 | FDA UDI | Class III | Active |
| Elecsys hGH CalSet | 5390133190 | FDA UDI | Class II | Active |
| Elecsys HCG STAT CalSet II | 09013296190 | FDA UDI | Class II | Active |
| PreciControl Anti-HBc II | 04927931161 | FDA UDI | Class II | Active |
| Ionify ControlSet Steroids and Vitamin D | 09646965160 | FDA UDI | Class I | Active |
| cobas Zika Control Kit | 08129690190 | FDA UDI | N/A | Active |
| Tina-quant Lipoprotein (a) Gen.2 Molarity | 08106126160 | FDA UDI | Class II | Active |
| Elecsys Beta-CrossLaps/serum | 09005773160 | FDA UDI | Class I | Active |
| Tobramycin ONLINE TDM Tobramycin | 4642503190 | FDA UDI | Class II | Unknown |
| Phosphate (Inorganic) ver.2 | 08058610190 | FDA UDI | Class I | Active |
| Elecsys Troponin I STAT Immunoassay | 5094798160 | FDA UDI | Class II | Active |
| Elecsys Anti-HCV II | 08837031190 | FDA UDI | Class II | Active |
| Elecsys Troponin T Gen 5 | 08469865160 | FDA UDI | Class II | Active |
| Elecsys HCG STAT CalSet | 3303071190 | FDA UDI | Class II | Active |
| cobas e 801 Immunoassay analyzer | 08454345001 | FDA UDI | Class I | Active |
| ONLINE DAT Amphetamines II | 08056781190 | FDA UDI | Class II | Active |
| Elecsys CrossLaps CalSet | 11972316122 | FDA UDI | Class I | Active |
| CalCheck Vitamin D total III | 09108912190 | FDA UDI | Class I | Active |
| Methadone II | 3046702190 | FDA UDI | Class II | Active |
| PreciControl TS | 06445918160 | FDA UDI | Class I | Active |
| Elecsys CalSet Troponin T Gen 5 STAT | 07398271160 | FDA UDI | Class II | Active |
| Elecsys Syphilis | 09014977190 | FDA UDI | Class II | Active |
| Elecsys PTH | 09744436190 | FDA UDI | Class II | Active |
| CalSet PTH | 07360894190 | FDA UDI | Class II | Unknown |
| Magnesium | 20737593322 | FDA UDI | Class I | Active |
| Lactate Gen.2 | 3183700190 | FDA UDI | Class I | Active |
| PreciControl Anti-HAV IgM | 11876368122 | FDA UDI | Class I | Active |
| Albumin Gen2 | 3183688122 | FDA UDI | Class II | Active |
| LDL-Cholesterol Gen.3 | 08057966190 | FDA UDI | Class I | Active |
| Albumin BCG method | 11970917216 | FDA UDI | Class II | Unknown |
| PreciControl Release HIV Gen II | 09367101190 | FDA UDI | U | Active |
| Procainamide | 4490975190 | FDA UDI | Class II | Active |
| PreciControl HBsAg Auto Confirm | 08741107190 | FDA UDI | Class II | Active |
| sFlT-1 CalSet | 05109531190 | FDA UDI | Class II | Active |
| UreaBUN | 4460715190 | FDA UDI | Class II | Active |
| Total Protein | 12000920216 | FDA UDI | Class II | Unknown |
| Elecsys CA 199 Immunoassay | 11776193122 | FDA UDI | Class II | Active |
| PreciControl Syphilis | 06923364162 | FDA UDI | Class I | Active |
| Elecsys HCG+ beta | 09744428190 | FDA UDI | Class II | Active |
| Cocaine II | 4490827190 | FDA UDI | Class II | Active |
| Anti-Tg CalSet | 09005030160 | FDA UDI | Class II | Active |
| Elecsys Tuptake Assay | 11731394122 | FDA UDI | Class II | Active |
| Elecsys FSH | 11775863122 | FDA UDI | Class I | Active |
| Nacetylprocainamide | 4853954190 | FDA UDI | Class II | Active |
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