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Trace America, Inc.

United StatesFDA applicant, unverified

Devices
22

What Trace America, Inc. makes

Trace America, Inc. manufactures reagents for clinical laboratory testing, including products for the COBAS MIRA analyzer, as well as various diagnostic reagents for measuring substances like HDL cholesterol, bicarbonate, alkaline phosphatase, porphobilinogen, glucose, magnesium, ammonia, uric acid, and lithium.

The company's portfolio consists of Class I and Class II medical devices listed in the FDA 510(k) registry, and it 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 Trace America, Inc. have in the registry?

The registry currently lists 22 devices for Trace America, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Trace America, Inc.'s devices?

Among its 22 most recently registered devices, Trace America, Inc. has devices listed in FDA 510(k) (22 devices).

What risk classes do Trace America, Inc.'s devices fall under?

Among its 22 most recently registered devices, the classes recorded for Trace America, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Trace America, Inc. in the registry?

The most recently registered devices listed for Trace America, Inc. include TRACE REAGENT LINE FOR THE COBAS MIRA, AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST), TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN and RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL.

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