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Bion Diagnostic Sciences

Country not established

Devices
1

What Bion Diagnostic Sciences makes

Bion Diagnostic Sciences makes the POLY STAT HCG TEST, which is a diagnostic test for detecting human chorionic gonadotropin (hCG) in clinical samples.

The POLY STAT HCG TEST is a Class II medical device listed in the FDA 510(k) registry, and the company is based in the United States.

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

Catalogue1

Newest first, rows 1-1 of 1

  • Poly Stat Hcg Test Ref K012559

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

Frequently asked questions

How many devices does Bion Diagnostic Sciences have in the registry?

The registry currently lists 1 device for Bion Diagnostic Sciences. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bion Diagnostic Sciences's devices?

Among its 1 most recently registered device, Bion Diagnostic Sciences has devices listed in FDA 510(k) (1 device).

What risk classes do Bion Diagnostic Sciences's devices fall under?

Among its 1 most recently registered device, the classes recorded for Bion Diagnostic Sciences's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Bion Diagnostic Sciences in the registry?

The most recently registered devices listed for Bion Diagnostic Sciences include POLY STAT HCG TEST.

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