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Pharmacia Diagnostics, Inc.

Also registered as Pharmacia Diagnostics AB, Pharmacia Diagnostics GmbH & Co. KG, Pharmacia Eni Diagnostics, Inc.

Country not established

Devices
12

What Pharmacia Diagnostics, Inc. makes

Pharmacia Diagnostics, Inc. manufactures serological test kits and immunoassay reagents for infectious disease diagnostics, including IgM and IgG antibody tests for viruses such as varicella-zoster, cytomegalovirus (CMV), toxoplasma, Epstein-Barr virus (EBV), and rubella. Their portfolio also includes specialized assay kits for measuring biomarkers like 17-OH progesterone.

The company’s products are regulated under FDA’s Class I and Class II device classifications, with some cleared via the 510(k) pathway. These diagnostics are listed in the FDA’s 510(k) registry, reflecting their authorised status for clinical use in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Frequently asked questions

How many devices does Pharmacia Diagnostics, Inc. have in the registry?

The registry currently lists 12 devices for Pharmacia Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Pharmacia Diagnostics, Inc.'s devices?

Among its 12 most recently registered devices, Pharmacia Diagnostics, Inc. has devices listed in FDA 510(k) (12 devices).

What risk classes do Pharmacia Diagnostics, Inc.'s devices fall under?

Among its 12 most recently registered devices, the classes recorded for Pharmacia Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Pharmacia Diagnostics, Inc. in the registry?

The most recently registered devices listed for Pharmacia Diagnostics, Inc. include SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS, DELFIA(R) 17 -OH-PROGESTERON KIT, PHARMACIA CMV IGM ELISA and PHARMACIA MUMPS IGG ELISA.

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