FDA applicant

Virion (U.S.), Inc.

Morristown, NJ5 decisions1987–19940 recalls

FDA records 5 decisions for Virion (U.S.), Inc. (Morristown, NJ) from 1987 to 1994: 5 510(k) clearances. Most are in product codes GMN (Antigens, Cf, Toxoplasma Gondii) and GRC (Antigen, Cf (Including Cf Control), Mumps Virus). 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 Virion (U.S.), Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Virion (U.S.), Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Virion (U.S.), Inc.

Which product codes does it file in?

What has FDA decided for it lately?