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Sterling Biochemical, Inc.

United StatesFDA applicant, unverified

Devices
15

What Sterling Biochemical, Inc. makes

Sterling Biochemical, Inc. manufactures reagent sets for clinical chemistry testing, including assays for lactic dehydrogenase, ALT/GPT, glucose (hexokinase), AST/GOT, total cholesterol, hydroxybutyrate dehydrogenase, alkaline phosphatase, serum cholinesterase, uric acid, creatine kinase, triglycerides, urea nitrogen, and creatine kinase.

These products are regulated as Class I and Class II devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The company is based in the United States.

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

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Frequently asked questions

How many devices does Sterling Biochemical, Inc. have in the registry?

The registry currently lists 15 devices for Sterling Biochemical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sterling Biochemical, Inc.'s devices?

Among its 15 most recently registered devices, Sterling Biochemical, Inc. has devices listed in FDA 510(k) (15 devices).

What risk classes do Sterling Biochemical, Inc.'s devices fall under?

Among its 15 most recently registered devices, the classes recorded for Sterling Biochemical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Sterling Biochemical, Inc. in the registry?

The most recently registered devices listed for Sterling Biochemical, Inc. include LACTIC DEHYDROGENASE REAGENT SET, ALT/GPT REAGENT SET, GLUCOSE(HEXOKINASE) REAGENT SET and AST/GOT REAGENT SET UV RATE.

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