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King'S Bay Intl., Inc.

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Devices
1

What King'S Bay Intl., Inc. makes

King’s Bay International, Inc. manufactures the Kings Bay Prelude One Step HCG Combo Kit, a diagnostic device used for detecting human chorionic gonadotropin (HCG) in urine samples, typically for pregnancy testing.

The device is classified as Class II under FDA regulations and is listed via 510(k) clearance. The company is based in the United States.

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

Catalogue1

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Frequently asked questions

How many devices does King'S Bay Intl., Inc. have in the registry?

The registry currently lists 1 device for King'S Bay Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list King'S Bay Intl., Inc.'s devices?

Among its 1 most recently registered device, King'S Bay Intl., Inc. has devices listed in FDA 510(k) (1 device).

What risk classes do King'S Bay Intl., Inc.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for King'S Bay Intl., Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from King'S Bay Intl., Inc. in the registry?

The most recently registered devices listed for King'S Bay Intl., Inc. include KINGS BAY PRELUDE ONE STEP HCG COMBO KIT.

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