FDA applicant

Genabio Diagnostics, Inc.

Bedford, MA2 decisions2024–20250 recalls

FDA records 2 decisions for Genabio Diagnostics, Inc. (Bedford, MA) from 2024 to 2025: 2 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and QYT (Over-The-Counter Covid-19 Antigen Test). Its devices cite 2 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2025

2024high 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Genabio Diagnostics, Inc. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Genabio Diagnostics, 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?