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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 24 of 35
DeviceModel / ReferenceRegistriesClassStatus
Rapid Cartridge C (iRapidC) 09511750190
FDA UDI
Class IActive
Elecsys N-MID Osteocalcin 07027591190
FDA UDI
Class IIActive
Tina-quant Antistreptolysin O 4489403190
FDA UDI
Class IActive
Vancomycin 5108420190
FDA UDI
Class IIUnknown
Tinaquant ß2Microglobulin 08105529190
FDA UDI
Class IIActive
cobas omni MGP Reagent MGP) 1.0
FDA UDI
Class IIActive
Elecsys Vitamin D CalCheck 5 6416632160
FDA UDI
Class IActive
CalSet Cortisol III Urine 09290940190
FDA UDI
Class IIActive
Glucose HK 08057800190
FDA UDI
Class IIActive
Calibrator ß2Microglobulin 08047545190
FDA UDI
Class IIUnknown
Elecsys Anti-HBs II 08498598160
FDA UDI
Class IIActive
Urisys 1100 Urine Analyzer 7790228001
FDA UDI
Class IIActive
Ceruloplasmin 08105553190
FDA UDI
Class IIActive
ONLINE DAT Cannabinoids II 08058644190
FDA UDI
Class IIActive
Elecsys PreciControl Tumor Marker 11776452160
FDA UDI
Class IActive
Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate activation 5850797190
FDA UDI
Class IActive
Tina-quant alpha1-Antitrypsin 11557599316
FDA UDI
Class IIUnknown
Abuscreen OnLine Barbiturates 20737976122
FDA UDI
Class IIActive
Elecsys Myoglobin CalSet 12178222122
FDA UDI
Class IIActive
Creatine Kinase 7190794190
FDA UDI
Class IIActive
Elecsys Syphilis 09015051162
FDA UDI
Class IIActive
Barbiturates Plus 4490754190
FDA UDI
Class IIActive
LSD CalibrationControl Pack 20766356122
FDA UDI
Class IIActive
Rheumatoid Factors II 5480167190
FDA UDI
Class IIActive
Elecsys Free PSA CalSet 03289796190
FDA UDI
Class IIIActive
Alkaline Phosphatase acc to IFCC Gen2 3333701190
FDA UDI
Class IIActive
Lidocaine 20757241322
FDA UDI
Class IIActive
COBAS Salicylate Calibrator 20759198122
FDA UDI
Class IIActive
Alkaline phosphatase acc to IFCC Gen2 4657373190
FDA UDI
Class IIActive
Cfas PUC 3121305122
FDA UDI
Class IIActive
Elecsys PreciControl Troponin 05095107160
FDA UDI
Class IActive
Tinaquant Hemoglobin A1c Gen2 4528123190
FDA UDI
Class IIActive
Glucoquant GlucoseHK 11876899216
FDA UDI
Class IIActive
HDL-Cholesterol Gen.4 07528582190
FDA UDI
Class IActive
Alkaline phosphatase liquid acc to IFCC 12173107122
FDA UDI
Class IIActive
Elecsys PreciControl Anti-HBc IgM 11876333160
FDA UDI
Class IIUnknown
Elecsys CalCheck T-Uptake 11776657160
FDA UDI
Class IActive
Elecsys Toxo IgG Immunoassay 4618815160
FDA UDI
Class IIActive
Roche 9180 Sodium electrode 03110419180
FDA UDI
Class IIActive
CalSet PTH 08928452190
FDA UDI
Class IActive
Lactate Gen.2 5401666190
FDA UDI
Class IActive
Amylase EPS ver2 3183742122
FDA UDI
Class IIActive
Tinaquant Complement C4 ver2 5991994190
FDA UDI
Class IIActive
Accutrend Plus Cholesterol strips 05213312160
FDA UDI
Class IActive
Phosphate ver.2 05401780190
FDA UDI
Class IActive
Elecsys PTH STAT CalSet 4894138190
FDA UDI
Class IIUnknown
cobas c 303 analytical unit 09793194001
FDA UDI
Class IActive
Gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz 08057796190
FDA UDI
Class IActive
cobas b 221 GLU/LAC/UREA (BUN) Cassette 03261085184
FDA UDI
Class IIActive
Aspartate aminotransferase acc to IFCC withwithout pyridoxal phosphate activat 4571100190
FDA UDI
Class IIActive

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