← Back to manufacturers

Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

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

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

Catalogue (1711)

Page 34 of 35
DeviceModel / ReferenceRegistriesClassStatus
Glucose Test System K113137
FDA 510(k)
Class IIActive
Calibrator For Automated Systems Proteins In Urine/Csf K040264
FDA 510(k)
Class IIActive
Elecsys Insulin Calcheck K001846
FDA 510(k)
Class IActive
Elecsys Hcg Test System K002148
FDA 510(k)
Class IIActive
Ontrak Testcup 5, Cat. 07 6481 7 K994030
FDA 510(k)
UActive
Elecsys FT4 IV K220456
FDA 510(k)
Class IIActive
Influenza A/B Rapid Test, Cat No 2158 663 K011684
FDA 510(k)
Class IIActive
Ca 125 Ii Calcheck K003967
FDA 510(k)
Class IActive
Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker K160915
FDA 510(k)
Class IIActive
Roche Diagnostics Cobas Elecsys Prolactin Ii Calset K052982
FDA 510(k)
Class IIActive
Elecsys Cortisol II, Cortisol II CalSet K152227
FDA 510(k)
Class IIActive
Elecsys Precicontrol Varia 3 K111506
FDA 510(k)
Class IActive
Roche Diagnostics Elecsys Afp Calset Ii K043095
FDA 510(k)
Class IIActive
Elecsys Rbc Folate Hemolyzed Reagent K051292
FDA 510(k)
Class IIActive
Cobas 6000 Series System K060373
FDA 510(k)
Class IIActive
Elecsys Folate Iii K141426
FDA 510(k)
Class IIActive
Tina-Quant Albumin Gen 2 K101203
FDA 510(k)
Class IIActive
Ca 125 Ii Calset Ii K140112
FDA 510(k)
Class IIActive
Cobas Integra Chloride Elctrode Gen.2 K060108
FDA 510(k)
Class IIActive
Ise Compensator K052193
FDA 510(k)
Class IIActive
cobas u 601 urinalysis test system K183432
FDA 510(k)
Class IIActive
Tina-Quant Crp (latex) K032336
FDA 510(k)
Class IIActive
Hdl-Cholesterol Plus 2nd Generation K033610
FDA 510(k)
Class IActive
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II K153301
FDA 510(k)
Class IIActive
Elecsys Testosterone Calset Ii K003411
FDA 510(k)
Class IIActive
Online Dat Ii Cocaine Ii K023281
FDA 510(k)
Class IIActive
Omni C Analyzer K013373
FDA 510(k)
Class IIActive
Elecsys Progesterone III CalSet K152526
FDA 510(k)
Class IIActive
Ammonia/Ethanol/Co2 Calibrator, Control Normal, Control Abnormal K031880
FDA 510(k)
Class IIActive
Accu-Chek Simplicity System K993829
FDA 510(k)
Class IIActive
Elecsys Troponin T Stat Test K040733
FDA 510(k)
Class IIActive
Elecsys Tsh Calset W/Models 04738551 K060754
FDA 510(k)
Class IIActive
Elecysys Shbg K102814
FDA 510(k)
Class IActive
Accu-Chek Aviva Plus Blood Glucose Monitoring System K101299
FDA 510(k)
Class IIActive
Elecsys Precicontrol Ts K140534
FDA 510(k)
Class IActive
Elecsys CA 15-3 II K181492
FDA 510(k)
Class IIActive
Elecsys Vitamin B12 Immunoassay, Calset Ii And Calcheck K060755
FDA 510(k)
Class IIActive
Roche Acetaminophen K013757
FDA 510(k)
Class IIActive
Elecsys Folate III K233060
FDA 510(k)
Class IIActive
Enzyme Immunoassay, Vancomycin K060586
FDA 510(k)
Class IIActive
Tina-Quant Crp (latex) Hs Test System (c-Reactive Protein (latex) High Sensitive) K042485
FDA 510(k)
Class IIActive
Elecsys Parathyroid Hormone Calcheck K993642
FDA 510(k)
Class IActive
Total Protein Urine/Csf Gen.3 K071239
FDA 510(k)
Class IIActive
Elecsys Probnp Ii Stat Immunoassay And Elecsys Probnp Ii Calset, Models 05390109-160, 04842472-190 K092649
FDA 510(k)
Class IIActive
Elecsys proBNP II, Elecsys proBNP II STAT K223637
FDA 510(k)
Class IIActive
Roche Diagnostics Tina-Quant D-Dimer On Cobas Integra; Roche Diagnostics Tina-Quant D-Dimer On Hitachi K002706
FDA 510(k)
Class IIActive
Elecsys Anti-HBe P190005
FDA PMA
Class IIActive
Elecsys Anti-Hcv Immunoassay On Mudular Analytics P090009
FDA PMA
Class IIActive
Elecsys Anti-Hcv Immunoassay On Cobas E 411 P090007
FDA PMA
Class IIActive
Elecsys Anti-Hbc Igm Assay (modular Analytics E170 Analyzer) P110025
FDA PMA
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.