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Roche Diagnostics Corp.

US

Last updated May 23, 2026

Information

Country
US
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Website
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Catalogue (1711)

Page 13 of 35
DeviceModel / ReferenceRegistriesClassStatus
Iron Gen.2 3183696122
FDA UDI
Class IActive
Glucose HK 4404483190
FDA UDI
Class IIActive
Methadone II 4490851190
FDA UDI
Class IIActive
Elecsys HBsAg II Auto Confirm 08741034162
FDA UDI
UActive
Elecsys HSV-1 IgG 08948844160
FDA UDI
Class IIActive
Tinaquant Albumin 4999622190
FDA UDI
Class IActive
Elecsys Vitamin B12 CalSet II 4572459190
FDA UDI
Class IIUnknown
Gentamicin 20737844322
FDA UDI
Class IIActive
Aspartate aminotransferase acc to IFCC withwithout pyridoxal phosphate activat 11876848216
FDA UDI
Class IIActive
Tinaquant CReactive Protein Gen3 4956885190
FDA UDI
Class IIActive
Accu-Chek Inform II Base Unit Light 5920353001
FDA UDI
Class IIActive
Elecsys Phospho-Tau (181P) CSF 08846693160
FDA UDI
Class IIActive
Lactate dehydrogenase liquid acc to IFCC 4796217190
FDA UDI
Class IIActive
PreciControl Anti-CCP 5031664160
FDA UDI
Class IActive
Valproic Acid 20737933322
FDA UDI
Class IIActive
CalSet Androstenedione 07679866190
FDA UDI
Class IIActive
gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz 3002721122
FDA UDI
Class IActive
Elecsys T Uptake CalSet 06528309190
FDA UDI
Class IIActive
Elecsys HCG STAT 07229569190
FDA UDI
Class IIActive
Elecsys tPSA 04491734160
FDA UDI
Class IIIActive
Roche 9180 Chloride electrode 03110451180
FDA UDI
Class IIActive
Elecsys Cortisol II 07027150190
FDA UDI
Class IIActive
Accu-Chek Inform II Base Unit Light 08376824190
FDA UDI
Class IIActive
Salicylate 11815172216
FDA UDI
Class IIUnknown
Total Protein Gen.2 08058652190
FDA UDI
Class IIActive
Vancomycin 4491050190
FDA UDI
Class IIUnknown
Tinaquant Myoglobin Gen2 5950759190
FDA UDI
Class IIActive
CalSet Tacrolimus 05889065190
FDA UDI
Class IIActive
Elecsys T4 09007741190
FDA UDI
Class IIActive
Elecsys IgE II 07027516190
FDA UDI
Class IIActive
PreciControl Anti-CMV 04784600162
FDA UDI
Class IIActive
Tina-quant Complement C3c Ver.2 08105537190
FDA UDI
Class IIActive
Elecsys Progesterone III 09755748190
FDA UDI
Class IActive
Tinaquant Myoglobin Gen2 4580010190
FDA UDI
Class IIActive
Glucose HK Gen3 5168791190
FDA UDI
Class IIActive
AmmoniaEthanolCO2 Calibrator 20751995190
FDA UDI
Class IIActive
Elecsys ACTH CalCheck 3562140190
FDA UDI
Class IActive
Elecsys Anti-HBc II 09014918160
FDA UDI
Class IIActive
Elecsys CEA 07027079190
FDA UDI
Class IIActive
Elecsys CEA Assay 11731629160
FDA UDI
Class IIActive
Sample supply unit 09793178001
FDA UDI
Class IActive
Tinaquant Apolipoprotein A1 ver2 5950686190
FDA UDI
Class IIActive
Roche CARDIAC TROP T Sensitive 11621947196
FDA UDI
Class IIActive
Control Set ß2Microglobulin 08362785190
FDA UDI
Class IUnknown
Preciset RF 12172828322
FDA UDI
Class IIActive
Direct Bilirubin 5975921190
FDA UDI
Class IIActive
Elecsys LH CalCheck 5 5917794160
FDA UDI
Class IActive
cobas e 602 Immunoassay Analyzer 05990378001
FDA UDI
Class IActive
Elecsys total PSA 08791686160
FDA UDI
Class IIIActive
Elecsys Folate RBC Calset 5944309160
FDA UDI
Class IIActive

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