FDA product code DDI: Transferrin, Fitc, Antigen, Antiserum, Control
DDI is the FDA product code for transferrin, fitc, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5880 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under DDI, from 2 different applicants. The average 510(k) review took 70 days (median 70).
Classification
| Field | Value |
|---|---|
| Device name | Transferrin, Fitc, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5880 |
| 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 DDI clearance
Top DDI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intl. Diagnostic Technology | 1 | 1984-07-11 |
| Gelman Instrument Co. | 1 | 1978-02-03 |
Most recent DDI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842071 | Intl. Diagnostic Technology | FIAX TRANSFERRIN TEST KIT | 1984-07-11 | 49 |
| K772074 | Gelman Instrument Co. | RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN | 1978-02-03 | 92 |
Recalls for DDI devices
openFDA lists no recalls for product code DDI.
Frequently asked questions
What is FDA product code DDI?
DDI is the FDA product code for transferrin, fitc, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5880 and reviewed by the Immunology panel.
What device class is DDI?
Class II, regulation 21 CFR 866.5880. Typical premarket route: 510(k).
How long does a 510(k) take for product code DDI?
Across 2 cleared submissions the average was 70 days from receipt to decision (median 70).
Which companies have the most DDI clearances?
Intl. Diagnostic Technology (1); Gelman Instrument Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DDI
- Run a recall and safety report across every DDI manufacturer
- Watch product code DDI 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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