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Roche Diagnostics Corp.

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

Country: US
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Catalogue (1711)

Page 28 of 35

Device	Model / Reference	Registries	Class	Status
Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys Vitamin D Calcheck 5	K113546	FDA 510(k)	Class II	Active
Elecsys PTH , Elecsys PTH STAT	K231927	FDA 510(k)	Class II	Active
Coaguchek Pt.s Test For Prothrombin Time Self-Testing	K030845	FDA 510(k)	Class II	Active
Accu-Chek Aviva Connect Blood Glucose Monitoring System	K141867	FDA 510(k)	Class II	Active
Roche Elecsys- Acth, Acth Calset, Acth Calcheck, Precicontrol Acth	K060585	FDA 510(k)	Class II	Active
Bilirubin Assay On The Omni S Analyzer	K040174	FDA 510(k)	Class I	Active
Modification To Calibrator For Automatic Systems (cfas)	K033501	FDA 510(k)	Class II	Active
Accu-Chek Compact System, Accu-Chek Compact Test Strips, Accu-Chek Compact Compact Controls	K004010	FDA 510(k)	Class II	Active
Roche Online Gentamicin	K020704	FDA 510(k)	Class II	Active
Cobas C 111 Analyzer	K071211	FDA 510(k)	Class II	Active
Precicontrol Clinchem Multi 1 And 2	K102016	FDA 510(k)	Class I	Active
Amphetamines Ii	K083764	FDA 510(k)FDA UDI	Class II	Active
Handheld Base Unit	K072920	FDA 510(k)	Class II	Active
Accu-Chek Advisor Insulin Guidance Software	K043529	FDA 510(k)	Class II	Active
Elecsys Troponin T Gen 5	K201441	FDA 510(k)	Class II	Active
Elecsys Toxo Igg Calcheck 5	K092888	FDA 510(k)	Class I	Active
Online Tdm Amika	K032279	FDA 510(k)	Class II	Active
Ontrak Teststik For Morphine 2000 (m2k)	K990409	FDA 510(k)	Class II	Active
Roche Diagnostics Tina-Quant Igm Gen.2	K040431	FDA 510(k)	Class II	Active
Modification To Elecsys Ck-Mb Stat, Elecsys Ck-Mb	K022654	FDA 510(k)	Class II	Active
Roche C.f.a.s. Dat Qualitative Plus Clinical Calibrator And Control Set Dat Clinical, Models 04590856 190, 04500873 190	K090939	FDA 510(k)	Class II	Active
Cobas C Bilirubin Total Gen.3	K131544	FDA 510(k)	Class II	Active
Modification To Tina-Quant D-Dimer Test System	K030740	FDA 510(k)	Class II	Active
Precinorm Proteins In Urine/Csf Precipath Proteins In Urine/Csr Controls	K040280	FDA 510(k)	Class I	Active
Elecsys T4 Calcheck 5	K112528	FDA 510(k)	Class I	Active
Elecsys Precicontrol Thyroab	K092320	FDA 510(k)	Class I	Active
Online Dat Propoxyphene Plus	K043303	FDA 510(k)	Class II	Active
Elecsys Ck-Mb Stat Immunoassay, Elecsys Ck-Mb Immunoassay	K132571	FDA 510(k)	Class II	Active
Precinorm Ck-Mb And Precipath Ck-Mb Controls	K062972	FDA 510(k)	Class I	Active
Glucose Hk New Formulation Test System	K062239	FDA 510(k)	Class II	Active
Cobas Integra Online Dat Ii Methadone Ii	K021512	FDA 510(k)	Class II	Active
Elecsys Rubella Igg Immunoassay	K072617	FDA 510(k)	Class II	Active
Roche Diagnostics Elecsys Folate Ii Assay	K031756	FDA 510(k)	Class II	Active
Tina-Quant Transferrin Ver.2	K012393	FDA 510(k)	Class II	Active
Calibrator For Automated Systems (c.f.a.s.) Proteins With Model 11355279160	K080607	FDA 510(k)	Class II	Active
Accu-Chek Aviva Expert System	K142089	FDA 510(k)	Class II	Active
Modification To:accu-Chek Pocket Compass Diabetes Management Software	K082595	FDA 510(k)	Class II	Active
Roche Oral Fluid Amphetamine, Roche Oral Fluid Dat Qual Cal B, Roche Oral Fluid Dat Control Set B, And Roche Oral Fluid	K110446	FDA 510(k)	Class II	Active
Cobas Lithium	K063684	FDA 510(k)	Class II	Active
Tina-Quant Apolipoprotein B Ver.2	K013207	FDA 510(k)	Class II	Active
Elecsysca 15-3 Ii Assay	K010588	FDA 510(k)	Class II	Active
Elecsys C-Peptide Calcheck	K040157	FDA 510(k)	Class I	Active
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH	K220134	FDA 510(k)	Class II	Active
CoaguChek XS Pro System	K180693	FDA 510(k)	Class II	Active
Accu-Chek Comfort Curve Test Strip	K010362	FDA 510(k)	Class II	Active
Ontrak Teststik For Methamphetamine, Cat. 1986686	K000096	FDA 510(k)	Class II	Active
Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions	K253490	FDA 510(k)	Class II	Active
Elecsys Parathyroid Hormone Test System	K992680	FDA 510(k)	Class II	Active
Elecsys Tg II	K221890	FDA 510(k)	Class II	Active
Accu-Check Combo System	K111353	FDA 510(k)	Class II	Active

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