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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 8 of 35
DeviceModel / ReferenceRegistriesClassStatus
Elecsys ?-CrossLaps/serum 07026960190
FDA UDI
Class IActive
Elecsys Insulin CalCheck 5 5917891160
FDA UDI
Class IActive
cobas&#x00AE MPX (480 tests) 06998917190
FDA UDI
N/AActive
Precipath Fructosamine 11174118122
FDA UDI
Class IIActive
PreciControl Anti-HAV 5524270160
FDA UDI
Class IActive
COBAS FP Free Valproic Acid Calibrators 20759031322
FDA UDI
Class IIActive
Elecsys CA 19-9 CalCheck 5 5917972160
FDA UDI
Class IActive
Elecsys PlGF 09015418160
FDA UDI
Class IIActive
Elecsys Prolactin II CalCheck 5 6267564160
FDA UDI
Class IActive
Chemstrip Micral Urine Test Strips 11544039160
FDA UDI
Class IActive
Elecsys Progesterone III 7092539190
FDA UDI
Class IActive
PreciControl Varia 5618860160
FDA UDI
Class IActive
Kidney KFRE Algorithm 09891986001
FDA UDI
Class IActive
Total Protein Gen2 3183734190
FDA UDI
Class IIActive
ISE Solution 3 20738077122
FDA UDI
Class IIActive
Tina-quant C-Reactive Protein IV 08057591190
FDA UDI
Class IIActive
Sodium electrode 10825468001
FDA UDI
Class IIActive
Elecsys T4 CalCheck 5 6347142160
FDA UDI
Class IActive
Elecsys CA 125 II CalCheck 7762011190
FDA UDI
Class IActive
cobas® HBV/HCV/HIV-1 Control Kit 1.0
FDA UDI
Class IIActive
Accutrend Plus Meter Kit 05346754160
FDA UDI
Class IIActive
Elecsys Anti-HCV II 08836981190
FDA UDI
Class IIActive
Elecsys Toxo IgM 04618858190
FDA UDI
Class IIActive
Benzodiazepines Plus 4499069190
FDA UDI
Class IIUnknown
Bilirubin Direct Gen.2 08056951190
FDA UDI
Class IIActive
Valproic Acid ONLINE TDM Valproic Acid 4642465190
FDA UDI
Class IIUnknown
Calcium 4580699190
FDA UDI
Class IIUnknown
Precinorm PUC 3121313122
FDA UDI
Class IActive
Elecsys free PSA 08828601160
FDA UDI
Class IIIActive
Serum Barbiturates 20766704322
FDA UDI
Class IIUnknown
Tinaquant IgG Gen2 5220718190
FDA UDI
Class IIActive
Tinaquant Complement C4 ver2 3001962322
FDA UDI
Class IIActive
Serum Barbiturates Calibrators 20766720322
FDA UDI
Class IIUnknown
cobas&#x00AE WNV (480 tests) 07001070190
FDA UDI
N/AActive
Uric Acid ver.2 5171857190
FDA UDI
Class IActive
cobas infinity POC IT solutions 08739170001
FDA UDI
Class IUnknown
PreciControl Anti-SARS-CoV-2 09216928190
FDA UDI
Class IIActive
Elecsys FT4 II 07027397190
FDA UDI
Class IIActive
Tina-quant CReactive Protein IV 07876432190
FDA UDI
Class IIActive
Elecsys proBNP II CalSet 09315314190
FDA UDI
Class IIActive
Elecsys Syphilis 06923348190
FDA UDI
Class IIActive
ISE Reference Electrolyte 11360981216
FDA UDI
Class IIActive
Elecsys FT4 IV 09043276160
FDA UDI
Class IIActive
Elecsys T4 07027885190
FDA UDI
Class IIActive
ONLINE TDM Digoxin 08057613190
FDA UDI
Class IIActive
Elecsys proBNP II CalCheck 5 5913268160
FDA UDI
Class IActive
Tinaquant Haptoglobin ver2 3005593322
FDA UDI
Class IIActive
Alkaline Phosphatase acc to IFCC Gen2 5166888190
FDA UDI
Class IIActive
Elecsys HCG Test System 3271749160
FDA UDI
Class IIActive
Cholinesterase Gen.2 08105561190
FDA UDI
Class IActive

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