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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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EUDAMED SRN: —
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Catalogue (1711)

Page 29 of 35

Device	Model / Reference	Registries	Class	Status
Elecsys Precicontrol Universal	K051687	FDA 510(k)	Class I	Active
Accu-Chek Inform Meter	K003846	FDA 510(k)	Class II	Active
Tdm N-Acetylprocainamide	K060738	FDA 510(k)	Class II	Active
Super Sani-Cloth/ Accu-Chek Inform Ii System	K130138	FDA 510(k)	Class II	Active
Roche Oral Fluid Opiates, Dat Qual Cal A, Dat Control Set A And Dat Sq Cal A	K093867	FDA 510(k)	Class II	Active
Roche Diagnostics Cardiac D-Dimer Rapid Assay; Roche Diagnostics Cardiac D-Dimer Controls	K033491	FDA 510(k)	Class II	Active
Elecsys Dhea-S Calset	K002760	FDA 510(k)	Class II	Active
Elecsys Rubella Igm Immunoassay	K092322	FDA 510(k)	Class II	Active
Elecsys BRAHMS PCT	K173927	FDA 510(k)	Class II	Active
Accuchek Instant Plus Dual Testing System, Accuchek Instant Plus Cholesterol, Accuchek Instant Plus Glucocose	K051376	FDA 510(k)	Class I	Active
Cobas Integra Reagent Cassette For Rheumatoid Factor Ii	K000534	FDA 510(k)	Class II	Active
Cobas C 501 Ise Indirect Na, K, Cl For Gen. 2	K132418	FDA 510(k)	Class II	Active
Elecsys Precicontrol Multianalyte	K033937	FDA 510(k)	Class I	Active
Roche Elecsys Pth Test System	K070709	FDA 510(k)	Class II	Active
Accu-Chek Performa System	K070585	FDA 510(k)	Class II	Active
Ontrak Testcup 5 M2k, Cat. 11 1850 1	K994017	FDA 510(k)	U	Active
Tdm Control Set	K060429	FDA 510(k)	Class I	Active
Elecsys Anti-SARS-CoV-2 S	K252280	FDA 510(k)	Class II	Active
Ptn Test Cartridges For Coaguchek Pro System, Ptn Controls For Coaguchek Pro System	K992492	FDA 510(k)	Class II	Active
Elecsys Estradiol III CalSet	K142021	FDA 510(k)	Class II	Active
Accu-Chek 360 Diabetes Management System	K080227	FDA 510(k)	Class II	Active
Roche Diagnostics Elecsys Precicontrol Cardiac	K032089	FDA 510(k)	Class I	Active
Elecsys Probnp Ii Calcheck 5	K092169	FDA 510(k)	Class I	Active
Elecsys C-Peptide Calset	K033873	FDA 510(k)	Class II	Active
Elecsys Ca 15-3 Test System	K001468	FDA 510(k)	Class II	Active
Elecsys Troponin I Calcheck 5	K100594	FDA 510(k)	Class I	Active
Roche Cobas Integra Serum Benzodiazepines (sbenz)	K991443	FDA 510(k)	Class II	Active
Elecsys Vitamin D total III	K210901	FDA 510(k)	Class II	Active
Coaguchek S System, Model 2138280	K994349	FDA 510(k)	Class II	Active
Elecsys Serum B-Crosslaps/Serum Immunoassay	K993706	FDA 510(k)	Class I	Active
Accu-Chek Advantage Module	K021513	FDA 510(k)	Class II	Active
Elecsys Anti-Tg Test System	K020672	FDA 510(k)	Class II	Active
Elecsys Probnp Immunoassay	K022516	FDA 510(k)	Class II	Active
Ontrak Teststik 2 For Cocaine/Thc, Cat. 1118579	K994164	FDA 510(k)	Class II	Active
Accu-Chek Inform Ii Blood Glucose Monitoring System	K121679	FDA 510(k)	Class II	Active
Elecsys Ft4 Ii Assay, Elecsys Ft4 Ii Calset	K131244	FDA 510(k)	Class II	Active
Elecsys Myoglobin Calcheck 5	K112113	FDA 510(k)	Class I	Active
Cobas U411 Test System	K093555	FDA 510(k)	Class I	Active
Roche Diagnostics Cobas Elecsys Anti-Tpo	K051890	FDA 510(k)	Class II	Active
Roche Diagnostics Tina-Quant Iga Gen.2	K040435	FDA 510(k)	Class II	Active
Cobas Integra Amikacin Mab	K991597	FDA 510(k)	Class II	Active
Elecsys Hsv-1 Igg Immunoassay Elecsys Precicontrol Hsv	K120625	FDA 510(k)	Class II	Active
Elecsys Cea Calcheck 5	K101856	FDA 510(k)	Class I	Active
Precicontrol Hba1c Norm; Precicontrol Hba1c Path	K103099	FDA 510(k)	Class I	Active
Modification To:roche Diagnostics Precinorm Universal And Precipath Universal Control Sera	K041227	FDA 510(k)	Class I	Active
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5	K160729	FDA 510(k)	Class II	Active
Elecsys BRAHMS PCT	K192815	FDA 510(k)	Class II	Active
Elecsys Myoglobin Stat, And Elecsys Myoglobin	K083260	FDA 510(k)	Class II	Active
Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3	K132828	FDA 510(k)	Class II	Active
Roche Diagnostics Influenza A/B Rapid Test	K993048	FDA 510(k)	Class II	Active

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