FDA product code · Microbiology

Antiserum, Fluorescent, Rabies Virus

Name: FDA decisions, review times, recalls and adverse event reports for product code GOI
Creator: 510(k) Report

GOIClass II21 CFR 866.3460510(k) required2 decisions since 19820 recalls

2 FDA decisions since 1982. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, microbiology panel

Twenty years of GOI at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · GOI

FDA has decided no GOI device since 2007.

Median 510(k) review, days · GOI

Too few GOI 510(k)s in any year since 2007 to give a median.

Recalls per year · GOI

No recall names GOI since 2007.

Adverse event reports per year · GOI

No MAUDE report names GOI since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in GOI? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Antiserum, Fluorescent, Rabies Virus

What has FDA decided in GOI lately?