FDA applicant

Rhigene, Inc.

Des Plaines, IL15 decisions2000–20040 recalls

FDA records 15 decisions for Rhigene, Inc. (Des Plaines, IL) from 2000 to 2004: 15 510(k) clearances. Most are in product codes LLL (Extractable Antinuclear Antibody, Antigen And…) and LJM (Antinuclear Antibody (Enzyme-Labeled)…). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided Rhigene, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rhigene, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rhigene, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Rhigene, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?