FDA product code DGE: Igd, Rhodamine, Antigen, Antiserum, Control
DGE is the FDA product code for igd, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under DGE, from 2 different applicants. The average 510(k) review took 73 days (median 73).
Classification
| Field | Value |
|---|---|
| Device name | Igd, Rhodamine, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DGE clearance
Top DGE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pb Diagnostic Systems, Inc. | 1 | 1992-03-18 |
| American Dade | 1 | 1987-07-21 |
Most recent DGE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K915838 | Pb Diagnostic Systems, Inc. | OPUS FERRITIN TEST SYSTEM | 1992-03-18 | 85 |
| K871972 | American Dade | STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY | 1987-07-21 | 61 |
Recalls for DGE devices
openFDA lists no recalls for product code DGE.
Frequently asked questions
What is FDA product code DGE?
DGE is the FDA product code for igd, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel.
What device class is DGE?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code DGE?
Across 2 cleared submissions the average was 73 days from receipt to decision (median 73).
Which companies have the most DGE clearances?
Pb Diagnostic Systems, Inc. (1); American Dade (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DGE
- Run a recall and safety report across every DGE manufacturer
- Watch product code DGE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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