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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 5 of 35| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| cobas e 601 for the cobas 6000 e 601 UL configuration | 07354452001 | FDA UDI | Class I | Active |
| alpha-Amylase EPS Pancreatic | 5167035190 | FDA UDI | Class II | Active |
| CReactive Protein Gen3 | 4956842190 | FDA UDI | Class II | Active |
| Tinaquant Hemoglobin A1c Gen2 Whole blood and Hemolysate Application | 5401640190 | FDA UDI | Class II | Active |
| CoaguChek XS Pro Kit | 05448964001 | FDA UDI | Class II | Active |
| Tina-quant Cystatin C Gen.2 | 6600174190 | FDA UDI | Class II | Unknown |
| Albumin Gen2 | 4657357190 | FDA UDI | Class II | Active |
| Elecsys Anti-HBc II | 07026790160 | FDA UDI | Class II | Unknown |
| Propoxyphene Plus | 08814716190 | FDA UDI | Class II | Active |
| Elecsys Anti-HAV II | 08086630190 | FDA UDI | Class II | Active |
| Bilirubin Direct | 20737496322 | FDA UDI | Class II | Active |
| FSH CalSet II | 09557440190 | FDA UDI | Class II | Active |
| CoaguChek XS Patient Self Testing Care Kit | 03666794001 | FDA UDI | Class II | Active |
| Factor V Leiden Kit | 1 | FDA UDI | Class II | Active |
| Phencyclidine Plus | 4499107190 | FDA UDI | U | Unknown |
| Elecsys CEA CalCheck 5 | 5917883160 | FDA UDI | Class I | Active |
| Elecsys Anti-Tg | 09005021190 | FDA UDI | Class II | Active |
| Elecsys HIV Duo | 08836973160 | FDA UDI | Class II | Active |
| Propoxyphene Plus | 4499140190 | FDA UDI | Class II | Unknown |
| Elecsys HCG CalSet | 3302652190 | FDA UDI | Class II | Active |
| Immunoglobulin A | 20737755322 | FDA UDI | Class II | Active |
| Elecsys T-Uptake | 07028105190 | FDA UDI | Class II | Active |
| Cholesterol Gen.2 | 04718917190 | FDA UDI | Class I | Active |
| CalSet Vitamin D total III | 09038116190 | FDA UDI | Class II | Active |
| Roche CARDIAC Control Troponin T | 11937553193 | FDA UDI | Class II | Active |
| PreciControl HBeAg | 11876376160 | FDA UDI | Class II | Active |
| Tina-quant Cystatin C Gen.2 | 6600263190 | FDA UDI | Class II | Active |
| Triglycerides | 20767107322 | FDA UDI | Class I | Active |
| AI ver2 Tinaquant Apolipoprotein AI ver2 | 3032612122 | FDA UDI | Class II | Active |
| Alanine aminotransferase acc. IFCC with or without PYP | 4718569190 | FDA UDI | Class I | Active |
| PreciControl Total-Tau | 07357028190 | FDA UDI | Class I | Active |
| Uric Acid ver.2 | 3183807190 | FDA UDI | Class I | Active |
| AmmoniaEthanolCO2 Control A AmmoniaEthanolCO2 Control Abnormal | 20753009190 | FDA UDI | Class I | Active |
| Bicarbonate liquid | 3289923190 | FDA UDI | Class II | Active |
| Elecsys PTH | 08928428190 | FDA UDI | Class II | Active |
| Elecsys FT3 III | 07027362190 | FDA UDI | Class II | Active |
| Methadone II | 3800571190 | FDA UDI | Class II | Unknown |
| Elecsys HE4 Assay | 5950929190 | FDA UDI | Class II | Active |
| Tinaquant Soluble Transferrin Receptor | 5950821190 | FDA UDI | Class II | Active |
| ONLINE DAT Cannabinoids II | 08771669190 | FDA UDI | Class II | Unknown |
| Tina-quant D-Dimer | 11556487316 | FDA UDI | Class II | Unknown |
| Ethyl Alcohol ETH | 11868152190 | FDA UDI | Class II | Unknown |
| CoaguChek XS Pro PT controls | 4625382160 | FDA UDI | Class II | Active |
| Elecsys Troponin T CalCheck 5 | 5917743160 | FDA UDI | Class I | Active |
| Elecsys Tacrolimus | 07251254190 | FDA UDI | Class II | Active |
| Cannabinoids II | 3046753190 | FDA UDI | Class II | Active |
| Elecsys CK-MB | 07027087190 | FDA UDI | Class II | Active |
| Theophylline | 5414482190 | FDA UDI | Class II | Active |
| Elecsys Anti-HBc IgM | 11820567160 | FDA UDI | Class II | Active |
| Unsaturated Iron-Binding Capacity | 08058776190 | FDA UDI | Class I | Unknown |
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