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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 21 of 35| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| pH Electrode | 3111717180 | FDA UDI | Class II | Active |
| Elecsys Syphilis | 07251378190 | FDA UDI | Class II | Active |
| ONLINE TDM Methotrexate | 09230815190 | FDA UDI | U | Active |
| CalChecks Total-Tau | 07546459190 | FDA UDI | Class I | Active |
| Elecsys Anti-HBc II | 07374160160 | FDA UDI | Class II | Unknown |
| C-Reactive Protein Gen.3 | 08057575190 | FDA UDI | Class II | Active |
| Elecsys Anti-Tg | 07026919190 | FDA UDI | Class II | Active |
| Lactate dehydrogenase liquid acc to IFCC | 4794940190 | FDA UDI | Class II | Active |
| AMH CalCheck 5 | 06331092190 | FDA UDI | Class I | Active |
| Elecsys CKMB Immunoassay | 5894808160 | FDA UDI | Class II | Active |
| Tina-quant Antistreptolysin O | 5219191190 | FDA UDI | Class I | Active |
| Phencyclidine Plus | 4490908190 | FDA UDI | U | Active |
| Creatine KinaseMB | 5401763190 | FDA UDI | Class II | Active |
| Elecsys AFP Assay | 4481798190 | FDA UDI | Class II | Active |
| Elecsys Toxo IgM | 09755861190 | FDA UDI | Class II | Active |
| Elecsys Anti-CCP CalCheck | 5133181160 | FDA UDI | Class I | Active |
| Magnesium Gen.2 | 06407358190 | FDA UDI | Class I | Active |
| Elecsys TSH | 08443432190 | FDA UDI | Class II | Active |
| Elecsys Testosterone II | 08946370190 | FDA UDI | Class I | Active |
| MTX Calibrator | 09533699190 | FDA UDI | Class II | Active |
| Mycophenolic Acid | 4357213190 | FDA UDI | Class II | Active |
| ISE Calibrator Kit | 4838106001 | FDA UDI | Class II | Active |
| Tina-quant Apolipoprotein A-1 ver.2 | 08105448190 | FDA UDI | Class II | Active |
| Elecsys CPeptide CalSet | 3184919190 | FDA UDI | Class II | Active |
| PreciControl MultiMarker | 5341787160 | FDA UDI | Class I | Active |
| Elecsys total PSA | 08791732190 | FDA UDI | Class III | Active |
| cobas b 221 S3 Fluid Pack | 3260933184 | FDA UDI | Class I | Active |
| PreciControl Anti-HBs | 11876317160 | FDA UDI | Class II | Active |
| Elecsys HSV-2 IgG | 08948909190 | FDA UDI | Class II | Active |
| Lactate Dehydrogenase acc to IFCC ver2 | 5169330190 | FDA UDI | Class II | Active |
| Elecsys Ferritin | 3737551160 | FDA UDI | Class II | Active |
| ONLINE TDM Methotrexate | 09230785190 | FDA UDI | U | Active |
| CalSet Phospho-Tau (181P) | 07357044190 | FDA UDI | Class II | Active |
| Total Protein Gen2 monocromatic | 4657586190 | FDA UDI | Class II | Active |
| Aspartate aminotransferase withwithout pyridoxal phosphate activation | 4657543190 | FDA UDI | Class II | Active |
| Elecsys FT3 III | 09005803190 | FDA UDI | Class II | Active |
| cobas e 402 analytical unit | 09793020001 | FDA UDI | Class I | Active |
| Anti-SARS-CoV-2 | 09203095190 | FDA UDI | Class II | Active |
| Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate activation | 20764957322 | FDA UDI | Class I | Active |
| TDM Control Set | 4521536190 | FDA UDI | Class I | Active |
| Roche 9180 Potassium electrode | 03110338180 | FDA UDI | Class II | Active |
| Uric Acid ver.2 | 04657608190 | FDA UDI | Class I | Active |
| CalCheck Phospho-Tau (181P) | 07546424190 | FDA UDI | Class I | Active |
| ONLINE DAT Phencyclidine Plus | 08058130190 | FDA UDI | U | Active |
| Lithium | 08057974190 | FDA UDI | Class II | Active |
| Immunoglobulin M | 20737771322 | FDA UDI | Class II | Active |
| Ammonia II | 07229593190 | FDA UDI | Class I | Active |
| Kinetic UV assay for ureaurea nitrogen | 11929470216 | FDA UDI | Class II | Active |
| PreciControl Anti-HCV | 03290379190 | FDA UDI | Class I | Active |
| Elecsys Vitamin D total II | 07028148190 | FDA UDI | Class II | Active |
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