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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 6 of 35
DeviceModel / ReferenceRegistriesClassStatus
Elecsys Ferritin 4491785160
FDA UDI
Class IIActive
Elecsys Total -Tau CSF 08846634160
FDA UDI
Class IIActive
ACET2 calibrator 7007515190
FDA UDI
Class IIActive
Elecsys IGF-1 07475918190
FDA UDI
Class IActive
Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation 4467388190
FDA UDI
Class IActive
Elecsys Syphilis 09015051190
FDA UDI
Class IIActive
Ureabun 4657616190
FDA UDI
Class IIActive
Tinaquant Ferritin Gen4 4885317190
FDA UDI
Class IIActive
Elecsys AMH 06331076160
FDA UDI
Class IIActive
Cardiac CReactive Protein Latex High Sensitive 5950864190
FDA UDI
Class IIActive
Elecsys T3 CalCheck 5 5917913160
FDA UDI
Class IActive
CEDIA Core TDM MultiCal 11815253216
FDA UDI
Class IIActive
Bicarbonate liquid 3289907190
FDA UDI
Class IIActive
Fructosamine 4537939190
FDA UDI
Class IIActive
Fe Standard 12146401216
FDA UDI
Class IIUnknown
COBAS Acetaminophen Calibrator 20758809122
FDA UDI
Class IIUnknown
Tina-quant IgA Gen.2 08057885190
FDA UDI
Class IIActive
CoaguChek XS PT strips 7797826160
FDA UDI
Class IIActive
Elecsys Digoxin Immunoassay 11820796160
FDA UDI
Class IIActive
Elecsys Anti-HAV IgM 07026773190
FDA UDI
Class IIActive
CoaguChek Vantus System 07729952160
FDA UDI
Class IIActive
Elecsys PCT CalCheck 5 05915686190
FDA UDI
Class IActive
Carbamazepine 4874625190
FDA UDI
Class IIUnknown
Elecsys proBNP II STAT CalSet 5390117190
FDA UDI
Class IIActive
Elecsys Anti-HBc II 09014926160
FDA UDI
Class IIActive
Creatinine plus ver2 5401470190
FDA UDI
Class IIActive
Elecsys Folate 07027290190
FDA UDI
Class IIActive
Elecsys Anti-TPO CalCheck 11820923190
FDA UDI
Class IActive
ONLINE TDM Phenytoin 08445567190
FDA UDI
Class IIActive
Elecsys PTH STAT Immunoassay 4892470160
FDA UDI
Class IIActive
Elecsys CYFRA 21-1 11820966160
FDA UDI
Class IIActive
Cocaine 08057508190
FDA UDI
Class IIActive
Bircarbonate liquid 5455308190
FDA UDI
Class IIActive
Ceruloplasmin 20764663322
FDA UDI
Class IIActive
Tinaquant Lipoprotein a Gen.2 5852625190
FDA UDI
Class IIActive
Acetaminophen 3255379160
FDA UDI
Class IIUnknown
Cholesterol Gen.2 3039773190
FDA UDI
Class IActive
Urea/Bun 08058806190
FDA UDI
Class IIActive
Elecsys AMH 08819378190
FDA UDI
Class IIActive
Elecsys HCG STAT Test System 3300811190
FDA UDI
Class IIActive
Elecsys PreciControl Anti-HBs 11876317160
FDA UDI
Class IIUnknown
Bilirubin Total Gen3 5795419190
FDA UDI
Class IIActive
cobas b 123 Fluid Pack 200 5403308001
FDA UDI
Class IIUnknown
Elecsys Rubella IgG 07027770190
FDA UDI
Class IIActive
Elecsys Cortisol II 6687733160
FDA UDI
Class IIActive
AMH CalSet 06331084190
FDA UDI
Class IIActive
Rapid Cartridge B (iRapidB) 09511741190
FDA UDI
Class IActive
PreciControl Anti-HAV II 08086672190
FDA UDI
Class IIActive
Creatine kinase 5401593190
FDA UDI
Class IIUnknown
Elecsys Phospho-Tau (181P) CSF 08846715190
FDA UDI
Class IIActive

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