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Roche Diagnostics Corp.

US

Last updated May 23, 2026

Information

Country
US
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Catalogue (1711)

Page 11 of 35
DeviceModel / ReferenceRegistriesClassStatus
cobas pro c 503 SBL-TL 08463727001
FDA UDI
Class IActive
Tina-quant a1-Antitrypsin ver.2 08101396190
FDA UDI
Class IIActive
cobas b 123 <4> POC system 5122287001
FDA UDI
Class IIActive
CalSet PTH 08243875190
FDA UDI
Class IIActive
ONLINE TDM Tobramycin 08253161190
FDA UDI
Class IIActive
PreciControl Toxo IgM 04618866190
FDA UDI
Class IActive
CalSet Vitamin D total II 07464240190
FDA UDI
Class IIActive
Elecsys AntiTSHR Immunoassay 4388780160
FDA UDI
Class IActive
Elecsys Folate III CalSet 7560001190
FDA UDI
Class IIActive
PreciControl HIV Gen II 06924107160
FDA UDI
Class IActive
Triglycerides 04657594190
FDA UDI
Class IActive
cobas infinity POC remote access 08420254001
FDA UDI
Class IUnknown
Elecsys FSH 09745840190
FDA UDI
Class IActive
Benzodiazepines Plus 4490789190
FDA UDI
Class IIActive
Bilirubin Total Gen.3 10421410190
FDA UDI
Class IIActive
ONLINE TDM Phenytoin 3516989190
FDA UDI
Class IIUnknown
Tinaquant IgA Gen2 3507246190
FDA UDI
Class IIActive
Tinaquant 2Microglobulin 5950783190
FDA UDI
Class IIActive
Elecsys Anti-HBs Immunoassay 11820524160
FDA UDI
Class IIUnknown
ONLINE TDM Quinidine 08252670190
FDA UDI
Class IIActive
Elecsys proBNP II Immunoassay 09315284190
FDA UDI
Class IIActive
HDL-Cholesterol Gen.4 07528566190
FDA UDI
Class IActive
Elecsys Anti-HBs CalCheck 04985354160
FDA UDI
Class IIUnknown
Elecsys Insulin Calset 12017504122
FDA UDI
Class IIActive
Tina-quant Haptoglobin ver.2 08106045190
FDA UDI
Class IIActive
Elecsys HBeAg immunoassay 11820583160
FDA UDI
Class IIUnknown
Cortisol II CalSet 6687750190
FDA UDI
Class IIActive
ISE indirect Na K Cl for Gen.2 4880455190
FDA UDI
Class IIActive
Elecsys Total PSA Immunoassay 04641655160
FDA UDI
Class IIIUnknown
CalCheck Androstenedione 07679874190
FDA UDI
Class IActive
Calcium Gen2 5061458190
FDA UDI
Class IIActive
Total T4 Thyroxine) 20739006322
FDA UDI
Class IIActive
TUptake 20739014322
FDA UDI
Class IIActive
Chemstrip 2 Gp Urine Test Strips 11895362160
FDA UDI
Class IIActive
Tinaquant Lipoprotein a Gen.2 5852633190
FDA UDI
Class IIActive
AFP CalSet II 09227261190
FDA UDI
Class IIActive
PreciControl HSV 5572207160
FDA UDI
Class IActive
Tina-quant ß2-Microglobulin 08047499190
FDA UDI
Class IIUnknown
Serum Benzodiazepines 20766690322
FDA UDI
Class IIUnknown
CalSet Folate 07396473190
FDA UDI
Class IIActive
Elecsys SHBG 3052001160
FDA UDI
Class IActive
Bilirubin Total Gen3 5795648190
FDA UDI
Class IIActive
Iron Gen.2 5169291190
FDA UDI
Class IActive
Tina-quant Soluble Transferrin Receptor 08252858190
FDA UDI
Class IIActive
ONLINE TDM N-acetylprocainamide 08252637190
FDA UDI
Class IIActive
PreciControl HIV; HIV-2+GrpO 06924115162
FDA UDI
UActive
AMH CalSet 09013326190
FDA UDI
Class IIActive
Elecsys Progesterone III 07027699190
FDA UDI
Class IActive
ISE Calibrator indirect / urine 4838149001
FDA UDI
Class IIActive
BCM for cobas 8100 08368449001
FDA UDI
Class IActive

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