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Roche Diagnostics Corp.

Also registered as Roche Diagnostics, Roche Diagnostics Corporation, Roche Diagnostics, Inc.

United StatesFDA applicant, unverified

Roche Diagnostics Corp. is a medical device manufacturer, with 469 devices listed in FDA 510(k), FDA PMA and FDA GUDID (FDA Class II, Class I, Unclassified and Class III) as of 15 Nov 2026.

Devices
469

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • FDA 510(k) 454
  • FDA PMA 15
  • FDA GUDID 3

A device listed in two registries counts in both.

Device classes
  • FDA Class II 359
  • FDA Class I 104
  • FDA Unclassified 5
  • FDA Class III 1

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.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue469

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Frequently asked questions

How many devices does Roche Diagnostics Corp. have in the registry?

The registry currently lists 469 devices for Roche Diagnostics Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Roche Diagnostics Corp.'s devices?

Among its 50 most recently registered devices, Roche Diagnostics Corp. has devices listed in FDA 510(k) (50 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Roche Diagnostics Corp.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Roche Diagnostics Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Roche Diagnostics Corp. in the registry?

The most recently registered devices listed for Roche Diagnostics Corp. include COAGUCHEK XS SYSTEM, cobas pulse blood glucose monitoring system, Elecsys EBV IgM and Elecsys EBV VCA IgG.

Generated automatically from registry data and not verified by a human reviewer.