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Roche Diagnostics Corp.

US

Last updated May 23, 2026

Information

Country
US
Address
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Website
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LinkedIn
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Facebook
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Email
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
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Catalogue (1711)

Page 19 of 35
DeviceModel / ReferenceRegistriesClassStatus
Accu-Chek Inform II Base Unit Light 08372284001
FDA UDI
Class IIActive
Elecsys AFP CalSet II 4487761190
FDA UDI
Class IIActive
CalSet II PTH 08928487190
FDA UDI
Class IActive
CalSet IGFBP-3 07574762190
FDA UDI
Class IIActive
Elecsys Digoxin 07027214190
FDA UDI
Class IIActive
Elecsys proBNP II STAT CalSet 09315306190
FDA UDI
Class IIActive
Elecsys Calcitonin 07027044190
FDA UDI
Class IIActive
Elecsys Anti-Tg CalCheck 3149056122
FDA UDI
Class IActive
Bircarbonate liquid 3607402190
FDA UDI
Class IIActive
Aspartate Aminotransferase acc. to IFCC II 08104719190
FDA UDI
Class IIActive
Elecsys ACTH Test System 3255751190
FDA UDI
Class IIActive
Alkaline phosphatase acc. to IFCC Gen.2 08056757190
FDA UDI
Class IIActive
Total Protein Urine/CSF Gen.3 08058679190
FDA UDI
Class IIActive
Elecsys ACTH 07026684190
FDA UDI
Class IIActive
Tina-quant CReactive Protein IV 07876033190
FDA UDI
Class IIActive
cobas omni Utility Channel Reagent Kit 07557272190
FDA UDI
Class IIActive
Lithium Electrode 21044303001
FDA UDI
Class IIActive
Elecsys Anti-TSHR 08496633190
FDA UDI
Class IIActive
Elecsys Rubella IgG CalCheck 5 5917832160
FDA UDI
Class IActive
Elecsys Chagas 09015582162
FDA UDI
UActive
Salicyclate 08058636190
FDA UDI
Class IIActive
Elecsys Folate RBC Assay 5944295160
FDA UDI
Class IIActive
Precinorm Protein 10557897160
FDA UDI
Class IActive
Elecsys Free PSA Immunoassay 03289788160
FDA UDI
Class IIIUnknown
PreciControl Vitamin D total III 09038124190
FDA UDI
Class IActive
Elecsys Total PSA Immunoassay 04491734160
FDA UDI
Class IIIUnknown
PreciControl HBsAg II Auto Confirm 08741107162
FDA UDI
N/AActive
Elecsys BRAHMS PCT 08828679190
FDA UDI
Class IIActive
Elecsys PTH CalCheck 5 5918103160
FDA UDI
Class IActive
Elecsys Toxo IgG 07028008190
FDA UDI
Class IIActive
Elecsys CA 125 II CalSet II 7030207190
FDA UDI
Class IIActive
Tina-quant Lipoprotein (a) Gen.2 Molarity 05852633160
FDA UDI
Class IIActive
Cannabinoids II 4491009190
FDA UDI
Class IIActive
Elecsys HBsAg Immunoassay 11820532160
FDA UDI
Class IIActive
Elecsys free PSA 07027320190
FDA UDI
Class IIIActive
Elecsys T3 09007733190
FDA UDI
Class IIActive
IRON Gen.2 10059605190
FDA UDI
Class IActive
cobas b 123 Sensor Cartridge BG/ISE 05170460001
FDA UDI
Class IIUnknown
Methaqualone 4853946190
FDA UDI
Class IIActive
CReactive Protein Gen3 5172373190
FDA UDI
Class IIActive
Precimat Glycerol 10166588130
FDA UDI
Class IActive
Elecsys Vitamin D Assay 6506780160
FDA UDI
Class IIActive
COCII Cocaine II 3800130190
FDA UDI
Class IIActive
Elecsys PlGF 09015434190
FDA UDI
Class IIActive
Calcium Gen.2 08057427190
FDA UDI
Class IIActive
Elecsys C-Peptide CalCheck 5 5918065160
FDA UDI
Class IActive
Elecsys Troponin I CalSet 5094828190
FDA UDI
Class IIActive
Chloride Electrode 3246353001
FDA UDI
Class IIActive
Calcium 11730240216
FDA UDI
Class IIUnknown
Elecsys TSH 08443432214
FDA UDI
Class IIActive

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