FDA product code · Immunology

Transferrin, Fitc, Antigen, Antiserum, Control

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

DDIClass II21 CFR 866.5880510(k) required2 decisions since 19780 recalls

2 FDA decisions since 1978. 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, immunology panel

Twenty years of DDI 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 · DDI

FDA has decided no DDI device since 2007.

Median 510(k) review, days · DDI

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

Recalls per year · DDI

No recall names DDI since 2007.

Adverse event reports per year · DDI

No MAUDE report names DDI 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 — DDI by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DDI? 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

Related product codes

Other codes under 21 CFR 866.5880.

DDD Transferrin, Rhodamine, Antigen, Antiserum…DDG Transferrin, Antigen, Antiserum, Control JNM Immunochemical, Transferrin

Transferrin, Fitc, Antigen, Antiserum, Control

What has FDA decided in DDI lately?

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