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Roche Diagnostics Corp.

US

Last updated May 23, 2026

Information

Country
US
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Catalogue (1711)

Page 10 of 35
DeviceModel / ReferenceRegistriesClassStatus
AmmoniaEthanolCO2 Control N AmmoniaEthanolCO2 Control Normal 20752401190
FDA UDI
Class IActive
FSH CalSet II 08932417190
FDA UDI
Class IIActive
Tinaquant Albumin Gen2 4469658190
FDA UDI
Class IActive
Bicarbonate Liquid 08057494190
FDA UDI
Class IIActive
PreciControl Release Anti-CMV 09366679190
FDA UDI
Class IIActive
PreciControl ISD 05889081160
FDA UDI
Class IActive
CalSet Anti-TSHR 08496641190
FDA UDI
Class IIActive
Tina-quant Complement C4 Ver.2 08105545190
FDA UDI
Class IIActive
Elecsys CA 125 II 09755586190
FDA UDI
Class IIActive
Elecsys HBsAg II 07914482160
FDA UDI
Class IIUnknown
Propoxyphene Plus 4490959190
FDA UDI
Class IIActive
Elecsys proBNP II 07027664190
FDA UDI
Class IIActive
Tinaquant C3c 11875078216
FDA UDI
Class IIActive
Elecsys Ferritin 07027273190
FDA UDI
Class IIActive
Prealbumin 08252645190
FDA UDI
Class IActive
Elecsys HIV combi PT 08924163160
FDA UDI
Class IIActive
a-Amylase EPS Pancreatic 08056820190
FDA UDI
Class IIActive
cobas 8000 c 502 Module 5964067001
FDA UDI
Class IActive
Cfas Proteins 11355279160
FDA UDI
Class IIActive
PreciControl Cortisol Urine 06687776190
FDA UDI
Class IActive
Cfas Lipids 5 ml 4373391190
FDA UDI
Class IIActive
Tinaquant Transferrin ver2 3015050122
FDA UDI
Class IIActive
Elecsys Total PSA CalSet II 04485220160
FDA UDI
Class IIIUnknown
Elecsys TSH 07028091190
FDA UDI
Class IIActive
Amphetamines II 4939425190
FDA UDI
Class IIActive
Elecsys Total PSA 09744860190
FDA UDI
Class IIIActive
Elecsys PreciControl Anti-HBc 04927931160
FDA UDI
Class IIUnknown
Homocysteine Enzymatic Assay 6542921190
FDA UDI
Class IIActive
ONLINE TDM Lidocaine 3376222190
FDA UDI
Class IIUnknown
Total Bilirubin Special 4774256160
FDA UDI
Class IIActive
Elecsys AFP 07026706190
FDA UDI
Class IIActive
PreciControl Syphilis 06923364190
FDA UDI
Class IActive
cobas b 221 <6> system 3337154001
FDA UDI
Class IIActive
Creatinine plus ver.2 08057524190
FDA UDI
Class IIActive
Elecsys Troponin T Gen 5 08469890160
FDA UDI
Class IIActive
Unsaturated Iron-Binding Capacity 5975808190
FDA UDI
Class IActive
Elecsys Vitamin B12 Immunoassay 4745736160
FDA UDI
Class IIUnknown
LDL-Cholesterol Gen.3 07005717190
FDA UDI
Class IActive
Creatine Kinase 08057460190
FDA UDI
Class IIActive
Elecsys PTH CalSet 11972219122
FDA UDI
Class IIUnknown
Aldolase 10123838160
FDA UDI
Class IActive
HDL-Cholesterol Gen.4 08057877190
FDA UDI
Class IActive
cobas omni Lysis Reagent LYS) 1.0
FDA UDI
Class IIActive
Elecsys FSH CalSet II 3032680122
FDA UDI
Class IIActive
Elecsys CKMB STAT Immunoassay 5957648160
FDA UDI
Class IIActive
PreciControl ThyroAB 05042666191
FDA UDI
Class IActive
Elecsys Estradiol III 6656021190
FDA UDI
Class IActive
Ionify Vitamin D 25 09634622160
FDA UDI
Class IIActive
Accu-Chek Inform II Base Unit Light 5920353001
FDA UDI
Class IIActive
Albumin Gen.2 08056692190
FDA UDI
Class IIActive

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