FDA applicant

Gentris Corporation

Morrisville, NC1 decision2006–20060 recalls

FDA records 1 decision for Gentris Corporation (Morrisville, NC) in 2006: 1 510(k) clearance. All are in product code NZB (Quality Control Material, Genetics, Dna). 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, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Gentris Corporation since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Gentris Corporation

Which product codes does it file in?

What has FDA decided for it lately?