FDA product code DGP: Ige, Fitc, Antigen, Antiserum, Control
DGP is the FDA product code for ige, fitc, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. FDA has cleared 4 510(k) submissions under DGP, from 4 different applicants. The average 510(k) review took 61 days (median 58).
Classification
| Field | Value |
|---|---|
| Device name | Ige, Fitc, 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 DGP clearance
Top DGP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biomerieux Vitek, Inc. | 1 | 1993-05-20 |
| Sclavo, Inc. | 1 | 1986-12-03 |
| Allergenetics | 1 | 1984-08-28 |
| Intl. Diagnostic Technology | 1 | 1984-08-28 |
Most recent DGP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K931224 | Biomerieux Vitek, Inc. | VIDAS TOTAL IGE (IGE) ASSAY | 1993-05-20 | 71 |
| K863327 | Sclavo, Inc. | IMMPULSE IGE ASSAY REAGENTS | 1986-12-03 | 98 |
| K842749 | Intl. Diagnostic Technology | FIAX TOTAL IGE TEST KIT | 1984-08-28 | 46 |
| K842969 | Allergenetics | ALLERGENETICS ALLER-SPECIFIC IGE SERUM | 1984-08-28 | 29 |
Recalls for DGP devices
openFDA lists no recalls for product code DGP.
Frequently asked questions
What is FDA product code DGP?
DGP is the FDA product code for ige, fitc, 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 DGP?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code DGP?
Across 4 cleared submissions the average was 61 days from receipt to decision (median 58).
Which companies have the most DGP clearances?
Biomerieux Vitek, Inc. (1); Sclavo, Inc. (1); Allergenetics (1); Intl. Diagnostic Technology (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DGP
- Run a recall and safety report across every DGP manufacturer
- Watch product code DGP 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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