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Serono Diagnostics, Inc.

Also registered as Serono-Baker Diagnostics, Inc.

United StatesFDA applicant, unverified

Devices
48

What Serono Diagnostics, Inc. makes

Serono Diagnostics, Inc. makes radioimmunoassay kits, immunoenzymatic assay kits, and automated differential hematology analyzers. Their products include kits for measuring various hormones, such as progesterone, prolactin, and estradiol, as well as tests for chlamydia and thyroid function.

The company's portfolio is regulated under Class I and Class II devices and is listed in the FDA 510(k) registry. The company is based in the US.

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

Catalogue48

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Frequently asked questions

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

The registry currently lists 48 devices for Serono Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.

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

Among its 48 most recently registered devices, Serono Diagnostics, Inc. has devices listed in FDA 510(k) (48 devices).

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

Among its 48 most recently registered devices, the classes recorded for Serono 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 Serono Diagnostics, Inc. in the registry?

The most recently registered devices listed for Serono Diagnostics, Inc. include PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH, ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT, SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) and SR1 ESTRADIOL ENZYME IMMUNOASSAY.

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