GPDClass I

Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus

21 CFR 866.3200 / Microbiology

GPD is the FDA product code for Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus, a class I device type, regulated under 21 CFR 866.3200. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: GPD
Device name: Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus
Regulation: 21 CFR 866.3200
Device class: Class I
Review panel: Microbiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Diagnostic Automation/ Cortez Diagnostics Inc.

Recent clearances

Product code GPD

FDA records hold no clearances under product code GPD.

Recent recalls

Product code GPD

FDA records show no recalls under product code GPD.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)