FDA product code · Microbiology

Hepatitis Delta Serological Reagents

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

LQIClass IIIPMA required1 decision since 19860 recalls

1 FDA decision since 1986. 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 LQI 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 · LQI

FDA has decided no LQI device since 2007.

Median 510(k) review, days · LQI

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

Recalls per year · LQI

No recall names LQI since 2007.

Adverse event reports per year · LQI

1in 2007

2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code LQI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	1
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 — LQI by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LQI? 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

Hepatitis Delta Serological Reagents

What has FDA decided in LQI lately?