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Roche Diagnostics Corp.

US

Last updated May 23, 2026

Information

Country
US
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Website
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Catalogue (1711)

Page 9 of 35
DeviceModel / ReferenceRegistriesClassStatus
Elecsys Anti-HCV Immunoassay 03290352160
FDA UDI
Class IIUnknown
Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation 08056773190
FDA UDI
Class IActive
Elecsys Vitamin D total III 09038078160
FDA UDI
Class IIActive
Elecsys Anti-HBc IgM 07026811160
FDA UDI
Class IIActive
Elecsys HBsAg II 07251076190
FDA UDI
Class IIUnknown
CalSet PlGF 05144701190
FDA UDI
Class IIActive
Tina-quant Lipoprotein (a) Gen.2 08106126190
FDA UDI
Class IIActive
Elecsys Anti-CMV 09118551162
FDA UDI
Class IIActive
Ammonia 20766682322
FDA UDI
Class IActive
cobas u 601 urine analyzer 06390498001
FDA UDI
Class IActive
Mycophenolic Acid 08105634190
FDA UDI
Class IIActive
Preciset DAT Plus I 3304671190
FDA UDI
Class IIActive
Kinetic UV assay for ureaurea nitrogen 11729691216
FDA UDI
Class IIActive
Elecsys PreciControl Anti-HCV 03290379160
FDA UDI
Class IIUnknown
Tinaquant Soluble Transferrin Receptor 20763454122
FDA UDI
Class IIActive
Tobramycin 4491033190
FDA UDI
Class IIActive
Lactate Gen.2 5171881190
FDA UDI
Class IActive
Creatinine Plus 11875566216
FDA UDI
Class IIUnknown
T4 Calibrators 20762016322
FDA UDI
Class IIUnknown
Elecsys HBeAg 11820583160
FDA UDI
Class IIActive
Elecsys Troponin T STAT Assay 4660307190
FDA UDI
Class IIActive
Elecsys Androstenedione 07679831190
FDA UDI
Class IActive
Direct Bilirubin 11986660018
FDA UDI
Class IIUnknown
cobas pro c 503 SBL - DL 08463743001
FDA UDI
Class IActive
Elecsys Rubella IgM 07027796190
FDA UDI
Class IIActive
Potassium Electrode 10825441001
FDA UDI
Class IIActive
Coaguchek Xs Pt Test 6 Strip 4625374160
FDA UDI
Class IIActive
Elecsys Myoglobin CalCheck 5 6270069160
FDA UDI
Class IActive
Elecsys proBNP II CalSet 4842472190
FDA UDI
Class IIActive
Elecsys C-Peptide 3184897190
FDA UDI
Class IActive
Transferrin ver 2 Tinaquant Transferrin ver2 3015114122
FDA UDI
Class IIActive
CoaguChek XS Patient Self Testing Care Kit 4837738001
FDA UDI
Class IIActive
PreciControl Lp(a) Gen.2 5852650160
FDA UDI
Class IActive
cobas p 501 post-analytical unit 05158494001
FDA UDI
Class IActive
Creatinine Jaff Gen2 compensated) 5401755190
FDA UDI
Class IIActive
Propoxyphene 20753602122
FDA UDI
Class IIActive
cobas omni Specimen Diluent SPEC DIL) 1.0
FDA UDI
Class IIActive
Elecsys HIV Duo 08836973190
FDA UDI
Class IIActive
Accutrend Plus Meter Kit 07769202001
FDA UDI
Class IIActive
cobas c 111 analyzer with ISE 04777433001
FDA UDI
Class IActive
HPLC Cartridge (iHPLC) 09511725190
FDA UDI
Class IActive
Fructosamine 08105677190
FDA UDI
Class IIActive
Accutrend Glucose Test Strips 11447475160
FDA UDI
Class IIActive
Calcium 4580664190
FDA UDI
Class IIUnknown
Glucose HK Gen. 3 05168791214
FDA UDI
Class IIActive
Elecsys HSV-1 IgG 07027494190
FDA UDI
Class IIActive
Elecsys hGH CalCheck 5 5942357160
FDA UDI
Class IActive
Tina-quant RF II 3004902122
FDA UDI
Class IIUnknown
Calcium Electrode 3111644180
FDA UDI
Class IIActive
Elecsys proBNP II Immunoassay 09315268160
FDA UDI
Class IIActive

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