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Roche Diagnostics Corp.

US

Last updated May 23, 2026

What Roche Diagnostics Corp. makes

Roche Diagnostics Corp. manufactures in vitro diagnostic (IVD) devices for clinical chemistry, including analyte profile controls and calibrators, as well as standalone tests for substances like total bilirubin, magnesium, human chorionic gonadotropin, and parathyroid hormone. Their portfolio also includes rapid urine analyte tests, chemiluminescent immunoassays, and nephelometric/turbidimetric assays for proteins such as transferrin. Point-of-care (POC) and remote-access testing systems, as well as troponin, myoglobin, and thyroid-stimulating hormone assays, are also part of their offerings.

The company’s devices are regulated under FDA’s classification system, spanning Class I, Class II, Class III, and unclassified (U) categories. These products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. regulatory requirements. Roche Diagnostics Corp. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

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US
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Catalogue (1711)

Page 32 of 35
DeviceModel / ReferenceRegistriesClassStatus
Accu-Check Compact Plus Blood Glucose Monitoring System K113614
FDA 510(k)
Class IIActive
Modification To Integra Reagent Cassette For Hemoglobin A1c K003120
FDA 510(k)
Class IIActive
Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.f.a.s. Cystatin C Calibrator, Cystatin C Gen.2 Control Set K141143
FDA 510(k)
Class IIActive
Cobas Integra Alp Ifcc Gen.2 K033185
FDA 510(k)
Class IIActive
Elecsys Ca 15-3 Calcheck K002353
FDA 510(k)
Class IIActive
Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF K221842
FDA 510(k)
Class IIActive
Online Dat Phencyclidine Plus K043305
FDA 510(k)
UActive
Elecsys TSH K190773
FDA 510(k)
Class IIActive
Pt S Test Strips And Controls For The Coaguchek S System, Models 2032422 And 3271404 K020831
FDA 510(k)
Class IIActive
Online Dat Ii Methadone Ii K021505
FDA 510(k)
Class IIActive
Elecsys Anti-Thyroid Peroxidase Antibody Test System K000155
FDA 510(k)
Class IIActive
Lightcycler Instrument Version 1.2 K033734
FDA 510(k)
Class IActive
Roche Cobas Integra Serum Barbiturates K991440
FDA 510(k)
Class IIActive
Modification To: Cobas Integra Ldl-Cholesterol Plus 2nd Generation K012287
FDA 510(k)
Class IActive
Tina-Quant Ferritin Gen. 4 K100538
FDA 510(k)
Class IIActive
Elecsys Anti-HAV II K190428
FDA 510(k)
Class IIActive
Accu-Chek Complete Meter K000364
FDA 510(k)
Class IIActive
Elecsys Hcg+b Calcheck 5 K092168
FDA 510(k)
Class IActive
Elecsys Ck-Mb Calcheck 5 K093582
FDA 510(k)
Class IActive
Elecsys TSH assay, cobas e 801 Immunoassay analyzer K162606
FDA 510(k)
Class IIActive
Elecsys Ck-Mb Stat Immunoassay K140404
FDA 510(k)
Class IIActive
Coaguchek Xs Plus System K071041
FDA 510(k)
Class IIActive
Tina-Quant Myoglobin Gen.2 Test System K061683
FDA 510(k)
Class IIActive
Precinorm Proteins In Urine/Csf (puc) And Precipath Puc K050026
FDA 510(k)
Class IIActive
Pt-S Test Strips For The Coaguchek System, Model# 2032422 K021190
FDA 510(k)
Class IIActive
Roche Diagnostics Hitachi Bicarbonate Liquid K032377
FDA 510(k)
Class IIActive
Roche Elecsys Folate Rbc; Roche Elecsys Folate Rbc Calset K103716
FDA 510(k)
Class IIActive
cobas pulse blood glucose monitoring system K220272
FDA 510(k)
Class IIActive
Elecsys AFP K220176
FDA 510(k)
Class IIActive
Elecsys Shbg Immunoassay K031717
FDA 510(k)
Class IActive
ONLINE TDM Phenytoin - Free Phenytoin application K230161
FDA 510(k)
Class IIActive
Roche-Creactive Protein (latex) K073277
FDA 510(k)
Class IIActive
Elecsys Precicontrol Troponin T K031990
FDA 510(k)
Class IActive
Elecsys Anti-SARS-CoV-2 K250768
FDA 510(k)
Class IIActive
Elecsys Progesterone III Cal Check 5 K150955
FDA 510(k)
Class IActive
Online Dat Barbiturates Plus K043211
FDA 510(k)
Class IIActive
Preciset Dat Plus I, Preciset Dat Plus Ii And Cfas Dat Qualitative Plus Calibrators K060645
FDA 510(k)
Class IIActive
Preciset Tdm I And Preciset Tdm Ii Calibrators K031856
FDA 510(k)
Class IIActive
Modification To Accu-Chek Active System K021827
FDA 510(k)
Class IIActive
Elecsys Precicontrol Cmv Igg, Elecsys Cmv Igg Immunoassay K131605
FDA 510(k)
Class IIActive
Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset Lp (a) Gen 2 Califrator Set Model 05852641160 K122722
FDA 510(k)
Class IIActive
Elecsys Precicontrol Anemia K051517
FDA 510(k)
Class IActive
Cobas Integra Ceruloplasmin K062379
FDA 510(k)
Class IActive
Elecsys Cortisol Test System K021218
FDA 510(k)
Class IIActive
Roche Diagnostics Urisys 1100 Urine Analyzer K033548
FDA 510(k)
Class IIActive
Elecsys Hcg+b Calcheck K010237
FDA 510(k)
Class IActive
Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 K162895
FDA 510(k)
Class IIActive
Elecsys Anti-SARS-CoV-2 K253839
FDA 510(k)
Class IIActive
Roche Acetaminophen Assay K110726
FDA 510(k)
Class IIActive
Elecsys Troponin T Calcheck 5 K092848
FDA 510(k)
Class IActive

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