FDA applicant

Healgen

Houston, TX1 decision2024–20240 recalls

FDA records 1 decision for Healgen (Houston, TX) in 2024: 1 De Novo grant. All are in product code SCA (Multi-Analyte Respiratory Virus Antigen…). 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 Healgen’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

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

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Other applicant names beginning “Healgen”

FDA records each applicant name separately; these may or may not be the same firm.

Healgen Scientific,, LLC 27

Healgen

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Healgen”