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Roche Diagnostics Corp.

US

Last updated May 23, 2026

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US
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Catalogue (1711)

Page 17 of 35
DeviceModel / ReferenceRegistriesClassStatus
Elecsys PTH 07251068190
FDA UDI
Class IIActive
Elecsys HBeAg 07027427190
FDA UDI
Class IIActive
Elecsys CMV IgG Assay 7309325160
FDA UDI
Class IIActive
Lipase colorimetric assay 3029590322
FDA UDI
Class IActive
Elecsys BRAHMS PCT 07301715190
FDA UDI
Class IIActive
Total Protein UrineCSF Gen3 5171954190
FDA UDI
Class IIActive
Alkaline phosphatase liquid acc to IFCC 12173158122
FDA UDI
Class IIActive
Tinaquant Albumin 3576108160
FDA UDI
Class IActive
Valproic Acid 08445575190
FDA UDI
Class IIActive
Elecsys Calcitonin CalSet 6445861190
FDA UDI
Class IIActive
Amikacin 4791959190
FDA UDI
Class IIActive
?-CrossLaps CalCheck 5 08133859190
FDA UDI
Class IActive
D-Dimer Control I/II 11556509216
FDA UDI
Class IIActive
cobas pro Sample Supply Unit 08464502001
FDA UDI
Class IActive
Preciset Lp(a) Gen.2 5852641160
FDA UDI
Class IIActive
Tinaquant Complement C3c ver2 3001938322
FDA UDI
Class IIActive
Elecsys AntiHCV II immunoassay 06427405160
FDA UDI
Class IIUnknown
PreciControl Toxo IgG 4618823160
FDA UDI
Class IActive
Transferrin ver 2 Tinaquant Transferrin ver2 3015084122
FDA UDI
Class IIActive
Elecsys ACTH Calset 3255760190
FDA UDI
Class IIActive
Elecsys Rubella IgG Immunoassay 4618793160
FDA UDI
Class IIActive
Ethanol Gen.2 08445672190
FDA UDI
Class IIUnknown
Preciset Lp(a) Gen.2 05852641190
FDA UDI
Class IIActive
Elecsys CMV IgG 07027117190
FDA UDI
Class IIActive
PreciControl HIV; HIV-2 + GrpO 06924115160
FDA UDI
Class IActive
Tinaquant Apolipoprotein AI ver2 6301703190
FDA UDI
Class IIActive
Elecsys PTH 08928380160
FDA UDI
Class IIActive
Tina-quant Apolipoprotein B ver.2 08105464190
FDA UDI
Class IIActive
Lipase colorimetric assay 08057982190
FDA UDI
Class IActive
ONLINE TDM Theophylline 3531066190
FDA UDI
Class IIUnknown
free PSA Calset 03289796190
FDA UDI
Class IIIActive
Fe Standard 12146401160
FDA UDI
Class IIActive
Elecsys FSH 08932387190
FDA UDI
Class IActive
Creatinine Jaff Gen2 4810716190
FDA UDI
Class IIActive
Elecsys Insulin 12017547122
FDA UDI
Class IActive
HDL-Cholesterol Gen.4 07528604190
FDA UDI
Class IUnknown
Procainamide 20737895322
FDA UDI
Class IIUnknown
Elecsys CA 125 II Assay 11776223161
FDA UDI
Class IIActive
Elecsys Toxo IgG CalCheck 5 5979650160
FDA UDI
Class IActive
cobas 6000 Core Unit 07354436001
FDA UDI
Class IActive
Control Set DAT I 3312950190
FDA UDI
Class IActive
Chemstrip 10 Ua Test Strips 11895354160
FDA UDI
Class IActive
Elecsys Anti-HAV II 08086664190
FDA UDI
Class IIActive
Elecsys Prolactin II 09755764190
FDA UDI
Class IActive
Elecsys sFlT-1 09015388190
FDA UDI
Class IIActive
Tinaquant 1Antitrypsin ver2 3005771322
FDA UDI
Class IIActive
Elecsys HBsAg II 08814864160
FDA UDI
Class IIUnknown
Homocysteine Control Kit 5142423190
FDA UDI
Class IActive
cobas b 221 SOL THB CALIBRATOR 3110923035
FDA UDI
Class IIActive
PreciControl Release Anti-HCV 09366652190
FDA UDI
UActive

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