DDNClass I

Beta-2-Glycoprotein I, Antigen, Antiserum, Control

21 CFR 866.5430 / Immunology

DDN is the FDA product code for Beta-2-Glycoprotein I, Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.5430. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: DDN
Device name: Beta-2-Glycoprotein I, Antigen, Antiserum, Control
Regulation: 21 CFR 866.5430
Device class: Class I
Review panel: Immunology
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

Recent clearances

Product code DDN

FDA records hold no clearances under product code DDN.

Recent recalls

Product code DDN

FDA records show no recalls under product code DDN.

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)