FDA applicant

Neumodx Molecular, Inc.

Ann Arbor, MI2 decisions2018–20230 recalls

FDA records 2 decisions for Neumodx Molecular, Inc. (Ann Arbor, MI) from 2018 to 2023: 2 510(k) clearances. Most are in product codes QEP (Nucleic Acid Detection System For Non-Viral…) and NJR (Nucleic Acid Amplification Assay System, Group…). 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, microbiology panel, where it files most

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

FDA decisions per year

1in 2023

2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Neumodx Molecular, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Neumodx Molecular, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?