Is this your brand? Sign in to claim ownership.

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
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (1711)

Page 30 of 35

Device	Model / Reference	Registries	Class	Status
Elecsys Phospho-Tau (181P) Plasma	K252163	FDA 510(k)	Class II	Active
Accu-Chek Compact System	K022171	FDA 510(k)	Class II	Active
Modification To Accu-Chek Inform Meter	K012210	FDA 510(k)	Class II	Active
Urisys 2400 Urine Test Strip	K012397	FDA 510(k)	Class II	Active
Roche Total Mycophenolic Acid Assay, Calibrators And Controls	K063520	FDA 510(k)	Class II	Active
Accu-Chek Go System	K040796	FDA 510(k)	Class II	Active
Ontrak Testcup 502, Model 3016641	K001417	FDA 510(k)	Class II	Active
The Cardiac Reader System	K000784	FDA 510(k)	Class II	Active
Tina-Quant D-Dimer Test System	K062203	FDA 510(k)	Class II	Active
ONLINE DAT Benzodiazepines II	K221765	FDA 510(k)	Class II	Active
Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet	K151786	FDA 510(k)	Class II	Active
Integra Reagent Cassette For Hemoglobin Alc	K990992	FDA 510(k)	Class II	Active
Elecsys Dhea-S Calcheck 5	K103402	FDA 510(k)	Class I	Active
Ferritin Generation 2	K031650	FDA 510(k)	Class II	Active
Elecsys Probnp Calcheck	K020883	FDA 510(k)	Class I	Active
Elecsys Fsh Calset Ii	K003409	FDA 510(k)	Class II	Active
Roche Cobas Integra Opiates 300/2000	K992890	FDA 510(k)	Class II	Active
Elecsys Probnp Ii Calcheck	K080147	FDA 510(k)	Class I	Active
Tina-Quant Cystatin C, Calibrator F.a.s. Cystatin C And Cystatin C Andcystatin C Control Set	K080811	FDA 510(k)	Class II	Active
Preciset Dat Thc And Preciset Dat Thc 20 Calibrators	K033246	FDA 510(k)	Class II	Active
Elecsys HSV-1 IgG (08948844160)	K220923	FDA 510(k)	Class II	Active
Accu-Chek Integra System	K050872	FDA 510(k)	Class II	Active
Elecsys B-Crosslaps Calcheck	K000042	FDA 510(k)	Class I	Active
Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF	K231348	FDA 510(k)	Class II	Active
Roche Online Tdm Phenytoin	K030428	FDA 510(k)	Class II	Active
CoaguChek Vantus System	K170960	FDA 510(k)	Class II	Active
Accu-Chek Compact Plus Blood Glucose Monitoring System	K081389	FDA 510(k)	Class II	Active
Elecsys Cortisol Test System	K000270	FDA 510(k)	Class I	Active
Roche Elecsys Folate Iii, Roche Elecsys Rbc Folate Hemolysing Reagent, Roche Elecsys Folate Iii Calset, Roche Elecsys	K082340	FDA 510(k)	Class II	Active
Elecsys Troponin I And Troponin I Stat Test Systems	K082699	FDA 510(k)	Class II	Active
Roche Diagnostics Omni S Analyzer	K032311	FDA 510(k)	Class II	Active
Elecsys Cortisol III	K242505	FDA 510(k)	Class II	Active
Modification To Roche Diagnostics Precinorm Proteins In Urine/Csf (puc) And Precipath Proteins In Urine/Csf (puc)	K041812	FDA 510(k)	Class I	Active
Cobas Integra Cholesterol Gen. 2	K031824	FDA 510(k)	Class I	Active
C-Reactive Protein (latex)	K083444	FDA 510(k)	Class II	Active
Elecsys CMV IgG	K220911	FDA 510(k)	Class II	Active
Roche Elecsys Anti-Ccp Immunoassay, Roche Elecsys Precicontrol Anti-Ccp	K081338	FDA 510(k)	Class II	Active
Accu-Chek Connect Diabetes Management App	K141929	FDA 510(k)	Class II	Active
Elecsys Precicontrol Multimarker	K102157	FDA 510(k)	Class I	Active
ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions	K253491	FDA 510(k)	Class II	Active
Ontrak Testcup M2k, Model Cat. 11 1849 8	K990399	FDA 510(k)	Class II	Active
Elecsys CMV IgM	K163569	FDA 510(k)	Class II	Active
Elecsys CA 15-3 II	K171605	FDA 510(k)	Class II	Active
Coaguchek Xs Plus Pst System	K092940	FDA 510(k)	Class II	Active
Tina-Quant Rheumatoid Factors Ii Test System	K002609	FDA 510(k)	Class II	Active
Elecsys Anti-Tshr Calcheck	K080643	FDA 510(k)	Class I	Active
Ontrak Teststik 3 For Cocaine/Morphine/Thc, Cat. 1118595	K994165	FDA 510(k)	Class II	Active
Elecsys Ferritin Calcheck 5	K102267	FDA 510(k)	Class I	Active
Integra Reagent Cassette For Apolipoprotein A-1	K990594	FDA 510(k)	Class II	Active
Elecsys Prolactin Ii Calcheck 5	K110613	FDA 510(k)	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.