DGEClass II

Igd, Rhodamine, Antigen, Antiserum, Control

21 CFR 866.5510 / Immunology

DGE is the FDA product code for Igd, Rhodamine, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5510. As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 1992-03-18, and no recalls.

Classification record

Product code: DGE
Device name: Igd, Rhodamine, Antigen, Antiserum, Control
Regulation: 21 CFR 866.5510
Device class: Class II
Review panel: Immunology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code DGE

By decision year

2 clearances under product code DGE with a decision year between 1987 and 1992, 1987 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code DGE by decision year
Year	Clearances
1987	1
1992	1

Applicants with the most clearances

Product code DGE

Applicants holding the most 510(k) clearances under product code DGE
Applicant	Clearances
American Dade	1
Pb Diagnostic Systems, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Kent Laboratories, Inc.

Recent clearances

Product code DGE

Recent recalls

Product code DGE

FDA records show no recalls under product code DGE.

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)