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David A. Fuccillo, Ph.D.

Country not established

Devices
9

What David A. Fuccillo, Ph.D. makes

The manufacturer produces enzyme-linked immunosorbent assay (EIA) test kits for detecting specific biomarkers, including RNP, SCL-70, RO, mitochondria, SM, histone, LA, JO-1, and ENA antigens. These kits are designed for laboratory use in diagnosing autoimmune and connective tissue diseases by quantifying antibody levels in patient samples.

The portfolio consists of Class II devices regulated under the FDA’s 510(k) clearance pathway. These test kits are listed in the FDA’s 510(k) database and are intended for use in the United States.

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

Catalogue9

Newest first, rows 1-9 of 9

  • Rnp Eia Test Kit Ref K935415

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

  • Scl-70 Eia Test Kit Ref K935418

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

  • Ro Eia Test Kit Ref K935416

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

  • Mitochondria Eia Test Kit Ref K940251

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

  • Sm Eia Test Kit Ref K935414

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

  • Histone Eia Test Kit Ref K940253

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

  • La Eia Test Kit Ref K935419

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

  • Jo-1 Eia Test Kit Ref K935417

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

  • Ena Eia Test Kit Ref K935413

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

Frequently asked questions

How many devices does David A. Fuccillo, Ph.D. have in the registry?

The registry currently lists 9 devices for David A. Fuccillo, Ph.D.. Devices recorded under merged duplicate company entries are counted once.

Which registries list David A. Fuccillo, Ph.D.'s devices?

Among its 9 most recently registered devices, David A. Fuccillo, Ph.D. has devices listed in FDA 510(k) (9 devices).

What risk classes do David A. Fuccillo, Ph.D.'s devices fall under?

Among its 9 most recently registered devices, the classes recorded for David A. Fuccillo, Ph.D.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from David A. Fuccillo, Ph.D. in the registry?

The most recently registered devices listed for David A. Fuccillo, Ph.D. include RNP EIA TEST KIT, SCL-70 EIA TEST KIT, RO EIA TEST KIT and MITOCHONDRIA EIA TEST KIT.

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