FDA product code DEI: Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control
DEI is the FDA product code for alpha-1-antitrypsin, fitc, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5130 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under DEI, from 2 different applicants. The average 510(k) review took 44 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5130 |
| 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 DEI clearance
Top DEI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intl. Diagnostic Technology | 1 | 1984-05-11 |
| Kallestad Laboratories, Inc. | 1 | 1977-12-22 |
Most recent DEI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K840867 | Intl. Diagnostic Technology | ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN | 1984-05-11 | 74 |
| K772250 | Kallestad Laboratories, Inc. | ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY | 1977-12-22 | 13 |
Recalls for DEI devices
openFDA lists no recalls for product code DEI.
Frequently asked questions
What is FDA product code DEI?
DEI is the FDA product code for alpha-1-antitrypsin, fitc, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5130 and reviewed by the Immunology panel.
What device class is DEI?
Class II, regulation 21 CFR 866.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code DEI?
Across 2 cleared submissions the average was 44 days from receipt to decision (median 44).
Which companies have the most DEI clearances?
Intl. Diagnostic Technology (1); Kallestad Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DEI
- Run a recall and safety report across every DEI manufacturer
- Watch product code DEI 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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