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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 18 of 35
DeviceModel / ReferenceRegistriesClassStatus
Cyclosporine Calibrators 20766305122
FDA UDI
Class IIActive
Elecsys HBsAg II 04687787160
FDA UDI
Class IIUnknown
ONLINE TDM Vancomyin Gen.3 06779336190
FDA UDI
Class IIActive
Elecsys proBNP II STAT Immunoassay 09315276160
FDA UDI
Class IIActive
Elecsys free PSA 08828610190
FDA UDI
Class IIIActive
Elecsys N-MID Osteocalcin CalCheck 5 6343589160
FDA UDI
Class IActive
Tinaquant Transferrin ver2 5588855190
FDA UDI
Class IIActive
Elecsys IGFBp-3 07574720190
FDA UDI
Class IActive
Phenobarbital 5027446190
FDA UDI
Class IIActive
Roche 9180 Calcium electrode 03110354180
FDA UDI
Class IIActive
PreciControl Release Anti-HBc II 09367039190
FDA UDI
UActive
Elecsys Troponin T Gen 5 CalCheck 5 05915759190
FDA UDI
Class IActive
Tinaquant Soluble Transferrin Receptor 12148315122
FDA UDI
Class IIActive
cobas® infinity central lab 09180443001
FDA UDI
Class IActive
a-Amylase EPS ver.2 08056811190
FDA UDI
Class IIActive
Tina-quant IgG Gen.2 08057915190
FDA UDI
Class IIActive
LDL-Cholesterol Gen.3 07005768190
FDA UDI
Class IActive
Elecsys Prolactin II 03203093190
FDA UDI
Class IActive
Elecsys CA 19-9 07027028190
FDA UDI
Class IIUnknown
Creatinine Plus 11875582216
FDA UDI
Class IIUnknown
Homocysteine Enzymatic Assay 5385415190
FDA UDI
Class IIActive
ISE Solution 1 20738050122
FDA UDI
Class IIActive
CalSet Troponin T Gen 5 08250499160
FDA UDI
Class IIActive
Tina-quant Albumin Gen.2 08056722190
FDA UDI
Class IActive
LH CalSet II 09557423190
FDA UDI
Class IIActive
Elecsys AMH 07026714190
FDA UDI
Class IIActive
Theophylline 4491025190
FDA UDI
Class IIActive
Elecsys CalCheck Testosterone 11776860160
FDA UDI
Class IActive
Elecsys Testosterone II 05200067160
FDA UDI
Class IActive
Total MPA Controls 4357230190
FDA UDI
Class IActive
Creatine Kinase 5168546190
FDA UDI
Class IIActive
ONLINE TDM Acetaminophen Gen.2 08056684190
FDA UDI
Class IIActive
Creatinine Jaff method 11875663216
FDA UDI
Class IIActive
Cocaine II 3800156190
FDA UDI
Class IIUnknown
ONLINE TDM Vancomycin Gen.3 08445605190
FDA UDI
Class IIActive
Elecsys Pro BNP II Immunoassay 4842464160
FDA UDI
Class IIActive
Elecsys DHEA-S CalCheck 5 5918014160
FDA UDI
Class IActive
ISE Potassium Electrode 4834925001
FDA UDI
Class IIActive
Elecsys AFP 09015086160
FDA UDI
Class IIActive
Total Protein UrineCSF Gen3 3333825190
FDA UDI
Class IIActive
Tinaquant Apolipoprotein B ver2 3032639122
FDA UDI
Class IIActive
ONLINE DAT Opiates II 08058113190
FDA UDI
Class IIActive
PreciControl CMV IgG 4784600160
FDA UDI
Class IActive
Opiates II 11986082216
FDA UDI
Class IIUnknown
alpha-Amylase EPS ver.2 5401496190
FDA UDI
Class IIActive
Lactate Gen.2 08057940190
FDA UDI
Class IActive
Tina-quant Cystatin C Gen.2 6600239190
FDA UDI
Class IIActive
PreciControl HbA1c norm 5479207190
FDA UDI
Class IActive
Creatine KinaseMB 4525299190
FDA UDI
Class IIActive
PreciControl Anti-HCV 3290379160
FDA UDI
Class IIActive

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