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Bioassay Systems Research Corp.

United StatesFDA applicant, unverified

Devices
3

What Bioassay Systems Research Corp. makes

Bioassay Systems Research Corp. produces human foreskin fibroblast (HFF) cells, cell culture lines for research applications, and a mycoplasma detection kit for contamination testing in cell cultures.

These products are classified as Class I medical devices under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3

Newest first, rows 1-3 of 3

  • Hff Gencells Ref K850990

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Cell Culture Lines Ref K780869

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Mycoplasma Detection Kit Ref K771867

    Active Regimes: 510(k) Registry: 510(k) Class:I

Frequently asked questions

How many devices does Bioassay Systems Research Corp. have in the registry?

The registry currently lists 3 devices for Bioassay Systems Research Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bioassay Systems Research Corp.'s devices?

Among its 3 most recently registered devices, Bioassay Systems Research Corp. has devices listed in FDA 510(k) (3 devices).

What risk classes do Bioassay Systems Research Corp.'s devices fall under?

Among its 3 most recently registered devices, the classes recorded for Bioassay Systems Research Corp.'s devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Bioassay Systems Research Corp. in the registry?

The most recently registered devices listed for Bioassay Systems Research Corp. include HFF GENCELLS, CELL CULTURE LINES and MYCOPLASMA DETECTION KIT.

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