FDA product code · Microbiology

Antigen, Iha, T. Cruzi

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

GNDClass I21 CFR 866.3870510(k) required0 decisions0 recalls

0 FDA decisions. 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 GND 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.

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

Planning a device in GND? 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

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Other codes under 21 CFR 866.3870.

GNE Antigen, Latex Agglutination, T. Cruzi LOO Reagent, Leishmanii Serological MIV Immunofluorescent Assay, T. Cruzi PIT Leishmania Spp. Antigen Detection Assay GNF Antigen, Cf, T. Cruzi OUZ Nucleic Amplification Assays For The Detection…MIU Enzyme Linked Immunosorbent Assay, T. Cruzi