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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 31 of 35

Device	Model / Reference	Registries	Class	Status
CoaguChek XS Plus System	K180684	FDA 510(k)	Class II	Active
Elecys Shbg Calcheck	K031698	FDA 510(k)	Class I	Active
Elecsys Anti-Tg	K222610	FDA 510(k)	Class II	Active
Roche Online Tdm Valproic Acid	K032049	FDA 510(k)	Class II	Active
Accu-Chek Compact Test Strip	K031755	FDA 510(k)	Class II	Active
Control Set Dat I, Contrl Set Dat Ii, Control Set Dat Iii, Control Set Amphetamine 1000 And Control Set Amphetamine 500	K080183	FDA 510(k)	Class I	Active
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions	K191899	FDA 510(k)	Class II	Active
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl	K162678	FDA 510(k)	Class II	Active
Elecsys He4, Elecsys He4 Calset, Elecsys Precicontrol He4, Elecsys He4 Calcheck 5	K112624	FDA 510(k)	Class II	Active
Roche/Hitachi Urinary/Csf Protein With Model(s) Cat #11877801	K072638	FDA 510(k)	Class II	Active
Elecsys Dhea-S Calcheck	K003772	FDA 510(k)	Class I	Active
Roche Online Theophylline	K020740	FDA 510(k)	Class II	Active
Cholinesterase Gen.2 Test System	K061093	FDA 510(k)	Class I	Active
Online Dat Benzodiazepines Plus	K043327	FDA 510(k)	Class II	Active
Elecsys proBNP II, Elecsys proBNP II STAT	K210546	FDA 510(k)	Class II	Active
Elecsys Ca 19-9 Immunoassay, Elecsys Ca 19-9 Calset	K050231	FDA 510(k)	Class II	Active
Elecsys Insulin Calcheck 5	K101075	FDA 510(k)	Class I	Active
Tdm Control Set, Model Cat# 04521536	K070200	FDA 510(k)	Class I	Active
Amplicor Ct/Ng Test For Neisseria Gonorrhoeae	K070172	FDA 510(k)	Class II	Active
Precinorm Universal Plus And Precipath Universal Plus Control Sera	K993360	FDA 510(k)	Class I	Active
Diabetes Assistant Software	K014139	FDA 510(k)	Class II	Active
Elecsys N-Mid Osteocalcin, Elecsys Osteocalcin Calset, Elecsys Osteocalcin Calcheck	K051297	FDA 510(k)	Class II	Active
CoaguChek XS Plus System	K253188	FDA 510(k)	Class II	Active
Crp Hs Test System	K003400	FDA 510(k)	Class II	Active
Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack, Roche Combitrol Plus B	K111188	FDA 510(k)	Class II	Active
Factor V Leiden Kit	DEN030005	FDA 510(k)	Class II	Active
Modification To Accu-Chek Active System	K021448	FDA 510(k)	Class II	Active
Elecsys Ige Ii Immunoassay	K061970	FDA 510(k)	Class II	Active
Accu-Chek Active Test System	K012324	FDA 510(k)	Class II	Active
Elecsys Tsh Calcheck 5	K093836	FDA 510(k)	Class I	Active
Tina-Quant Hemoglobin A1c Gen.2 Test System	K072714	FDA 510(k)	Class II	Active
Elecsys HCG STAT	K203227	FDA 510(k)	Class II	Active
Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5	DEN150057	FDA 510(k)	Class II	Active
Tina-Quant Complement C4 Test System	K012359	FDA 510(k)	Class II	Active
Elecsys Syphilis	K211302	FDA 510(k)	Class II	Active
ACCU-CHEK Performa Blood Glucose Monitoring System	K133741	FDA 510(k)	Class II	Active
Calibrator For Automated Systems	K011226	FDA 510(k)	Class II	Active
Elecsys Folate Iii Calcheck 5	K094031	FDA 510(k)	Class I	Active
Elecsys Dhea-S	K003174	FDA 510(k)	Class I	Active
Elecsys Cortisol Test System, Addition Of Saliva Sample Type	K043175	FDA 510(k)	Class II	Active
C-Reactive Protein (latex) High Sensitive Test System For Cobas Integra Instruments	K053603	FDA 510(k)	Class II	Active
Elecsys Ca 19-9 Calcheck 5	K101365	FDA 510(k)	Class I	Active
Roche Elecsys Toxo Igg Test System, Roche Elecsys Precicontrol Toxo Igg	K073501	FDA 510(k)	Class II	Active
Elecsys Cortisol Calcheck	K000576	FDA 510(k)	Class II	Active
Ontrak Testcard 9	K012396	FDA 510(k)	Class II	Active
Ontrak Testcup-5 M2k	K990337	FDA 510(k)	Class II	Active
Accu-Chek Ultrflex Infusion Set	K101196	FDA 510(k)	Class II	Active
Ise Indirect Na, K, Cl For Gen.2	K053165	FDA 510(k)	Class II	Active
Creatinine Plus	K003261	FDA 510(k)	Class II	Active
Cobas Integra Bilirubin Direct Gen.2	K123965	FDA 510(k)	Class II	Active

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