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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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Email
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PRRC Contact
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EUDAMED SRN
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Catalogue (1711)

Page 22 of 35
DeviceModel / ReferenceRegistriesClassStatus
TSH CalCheck 5 05917824160
FDA UDI
Class IActive
Cardiac CReactive Protein Latex High Sensitive 5401607190
FDA UDI
Class IIActive
Elecsys CA 153 II Assay 3045838160
FDA UDI
Class IIActive
cobas Elecsys AntiTPO 6368590190
FDA UDI
Class IIActive
Elecsys T3 09007725190
FDA UDI
Class IIActive
Tinaquant Ferritin Gen4 5123895190
FDA UDI
Class IIActive
Tina-quant D-Dimer 08105618190
FDA UDI
Class IIActive
Elecsys BRAHMS PCT 5056888200
FDA UDI
Class IIActive
Elecsys Folate III Assay 7559992160
FDA UDI
Class IIActive
Ammonia 05975581190
FDA UDI
Class IActive
Elecsys Anti-HCV II 06427405160
FDA UDI
Class IIActive
CReactive Protein Latex) 20764930322
FDA UDI
Class IIActive
D-Dimer Calibrator 11556495216
FDA UDI
Class IIActive
Elecsys FT4 CalCheck 11776665160
FDA UDI
Class IActive
Precipath PUC 3121291122
FDA UDI
Class IActive
CalSet CK-MB 07394667190
FDA UDI
Class IIActive
C.f.a.s. PAC 3555941190
FDA UDI
Class IIActive
cobas Elecsys Prolactin II CalSet 3277356190
FDA UDI
Class IIActive
PreciControl HBsAg II 04687876160
FDA UDI
Class IIActive
Total MPA Calibrators 4357221190
FDA UDI
Class IIActive
no MS ISE Calibrator Direct) 20763055122
FDA UDI
Class IIActive
Elecsys CKMB CalSet 5957664190
FDA UDI
Class IActive
Elecsys Ferritin CalCheck 5 5917875160
FDA UDI
Class IActive
Elecsys T3 07027869190
FDA UDI
Class IIActive
Tina-quant a1-Acid Glycoprotein Gen.2 08100276190
FDA UDI
Class IActive
cobas&#x00AE WNV (96 tests) 07001061190
FDA UDI
N/AActive
ONLINE DAT Benzodiazepines Plus 08056919190
FDA UDI
Class IIActive
Elecsys C-Peptide 07027168190
FDA UDI
Class IActive
Free Valproic Acid Controls 20759058322
FDA UDI
Class IIActive
PreciControl Vitamin D total II 07464266190
FDA UDI
Class IActive
Elecsys Cortisol Test System 11875116160
FDA UDI
Class IIActive
Elecsys Anti-HAV 07026757190
FDA UDI
Class IIActive
CEDIA Antibiotic TDM Multi-Cal 11815245216
FDA UDI
Class IIUnknown
cobas b 221 GLU Cassette 03260895184
FDA UDI
Class IIActive
Tinaquant Haptoglobin 11557629316
FDA UDI
Class IIActive
Elecsys Folate III 4476433160
FDA UDI
Class IIUnknown
free PSA CalCheck 03500373190
FDA UDI
Class IIIUnknown
cobas b 221 S2 Fluid Pack 3260925184
FDA UDI
Class IIActive
Cholesterol Gen.2 05168538190
FDA UDI
Class IActive
Creactive protein latex) 5401615190
FDA UDI
Class IIActive
CoaguChek XS Pro Kit 5530199160
FDA UDI
Class IIActive
Elecsys HSV-2 IgG 07027508190
FDA UDI
Class IIActive
Iron Gen.2 08057931190
FDA UDI
Class IActive
cobas&#x00AE MPX Control Kit 06999069190
FDA UDI
N/AActive
Elecsys Myoglobin 07027583190
FDA UDI
Class IIActive
Total Protein 12000903216
FDA UDI
Class IIUnknown
Elecsys FT4 II CalSet 6437290160
FDA UDI
Class IIActive
Precipath Protein 11333127160
FDA UDI
Class IActive
cobas® HIV1 Quantitative nucleic acid test for use on the cobas® 68 88 Systems 06998836190
FDA UDI
Class IIActive
ONLINE DAT Barbiturates Plus 08056889190
FDA UDI
Class IIActive

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