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Gelco Diagnostics, Inc.

United StatesFDA applicant, unverified

Devices
14

What Gelco Diagnostics, Inc. makes

Gelco Diagnostics, Inc. manufactures goat-derived antibody reagents used for detecting human immunoglobulins, including affinity-purified and FITC-conjugated forms targeting specific immunoglobulin chains such as kappa, lambda, IgG, IgA, and IgM.

These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.

AI-generated from registry data, 30 Sep 2026. Not verified by deviCERTS or the manufacturer.

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Frequently asked questions

How many devices does Gelco Diagnostics, Inc. have in the registry?

The registry currently lists 14 devices for Gelco Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Gelco Diagnostics, Inc.'s devices?

Among its 14 most recently registered devices, Gelco Diagnostics, Inc. has devices listed in FDA 510(k) (14 devices).

What risk classes do Gelco Diagnostics, Inc.'s devices fall under?

Among its 14 most recently registered devices, the classes recorded for Gelco Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Gelco Diagnostics, Inc. in the registry?

The most recently registered devices listed for Gelco Diagnostics, Inc. include GOAT ANTI-HUMAN KAPPA AFFINITY, GOAT ANTI-HUMAN LAMBA, FITC GOAT ANTI-HUMAN KAPPA AFFINITY and GOAT ANTI-HUMAN IMMUNOGLOBULINS-.

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