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Roche Diagnostics Corp.

US

Last updated May 23, 2026

Information

Country
US
Address
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Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
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Catalogue (1711)

Page 20 of 35
DeviceModel / ReferenceRegistriesClassStatus
Potassium electrode 10825441001
FDA UDI
Class IIActive
Bilirubin Direct Gen.2 (Doumas standardization) 05168384190
FDA UDI
Class IIActive
cobas c 501 Module 4745914001
FDA UDI
Class IUnknown
Elecsys Tg II 08906556160
FDA UDI
Class IIActive
Accutrend Cholesterol Controls 5219957001
FDA UDI
Class IActive
Elecsys T3 CalSet 11731548122
FDA UDI
Class IIActive
Tina-quant Hemoglobin A1cDx Gen.3 08056668190
FDA UDI
Class IIActive
cobas b 123 Fluid Pack COOX 700 5170052001
FDA UDI
Class IIUnknown
Elecsys CrossLapsserum Immunoassay 11972308160
FDA UDI
Class IActive
cobas b 123 Fluid Pack 700 5403286001
FDA UDI
Class IIUnknown
Glucoquant GlucoseHK 11929534216
FDA UDI
Class IIActive
BicarbonateBicarbonate STAT 5446376191
FDA UDI
Class IIActive
Digoxin 20737836322
FDA UDI
Class IIActive
CalSet PTH STAT 08243930190
FDA UDI
Class IIActive
Tinaquant Complement C3c ver2 5991986190
FDA UDI
Class IIActive
Elecsys IgE II Immunoassay 4827031190
FDA UDI
Class IIActive
Triglycerides/Glycerol Blanked 05976006190
FDA UDI
Class IActive
Lactate Dehydrogenase acc. to IFCC ver.2 5401674190
FDA UDI
Class IIActive
CoaguChek XS Plus Professional Care Kit 04562780001
FDA UDI
Class IIActive
Tinaquant IgA Gen2 5219205190
FDA UDI
Class IIActive
Calibration Strip (Urisys 1100, cobas u 411) 11379194160
FDA UDI
Class IIActive
Cfas DAT Qualitative Plus Clinical 4590856190
FDA UDI
Class IActive
Tinaquant Hemoglobin A1c III 5336163190
FDA UDI
Class IIActive
Elecsys Androstenedione 07679840190
FDA UDI
Class IActive
PreciControl HBsAg II 04687876162
FDA UDI
UActive
Elecsys Troponin T CalSet 4856627190
FDA UDI
Class IIActive
Creatinine Plus 11775685216
FDA UDI
Class IIUnknown
cobas c 111 analyzer 4528778001
FDA UDI
Class IActive
Accutrend Glucose Controls 5213231160
FDA UDI
Class IActive
PreciControl Rubella IgM 09787518190
FDA UDI
Class IActive
Elecsys PTH Immunoassay 11972103160
FDA UDI
Class IIActive
Elecsys CYFRA 21-1 CalSet 11820974322
FDA UDI
Class IIActive
CoaguChek XS Plus Professional Care Kit 5021537001
FDA UDI
Class IIActive
Elecsys HSV2 IgG Immunoassay 5572193160
FDA UDI
Class IIActive
Tinaquant IgM Gen2 5220726190
FDA UDI
Class IIActive
Elecsys DHEA-S 3000087122
FDA UDI
Class IActive
Elecsys CalCheck FT 3 3554538190
FDA UDI
Class IActive
Elecsys Ferritin CalSet 3737586190
FDA UDI
Class IIActive
navify Quality Control 09871179001
FDA UDI
Class IActive
ONLINE TDM Phenytoin 08058601190
FDA UDI
Class IIUnknown
CalSet Myoglobin 07394675190
FDA UDI
Class IIActive
Creatinine Jaffe Gen.2 08057532190
FDA UDI
Class IIActive
Elecsys Myoglobin Immunoassay 12178214160
FDA UDI
Class IIActive
C.f.a.s. Cystatin C 4975901191
FDA UDI
Class IIActive
Elecsys AFP 09015060160
FDA UDI
Class IIActive
Serum Benzodiazepines Cals 20766712322
FDA UDI
Class IIActive
Elecsys Troponin T Gen 5 08250472160
FDA UDI
Class IIActive
Elecsys SHBG CalSet 3052028190
FDA UDI
Class IIActive
PreciControl HbA1c path 5912504190
FDA UDI
Class IActive
Aspartate aminotransferase acc to IFCC withwithout pyridoxal phosphate activat 4571118190
FDA UDI
Class IIActive

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