FDA product code DAB: Haptoglobin, Fitc, Antigen, Antiserum, Control
DAB is the FDA product code for haptoglobin, fitc, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5460 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under DAB, from 3 different applicants. The average 510(k) review took 76 days (median 92).
Classification
| Field | Value |
|---|---|
| Device name | Haptoglobin, Fitc, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5460 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DAB clearance
Top DAB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Binding Site, Ltd. | 1 | 1991-12-09 |
| Intl. Diagnostic Technology | 1 | 1984-10-05 |
| Gelman Instrument Co. | 1 | 1978-02-03 |
Most recent DAB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K913670 | The Binding Site, Ltd. | HAPTOGLOBIN IMMUNOLOGICAL TEST KIT | 1991-12-09 | 112 |
| K843570 | Intl. Diagnostic Technology | FIAX HAPTOGLOBIN TEST KIT | 1984-10-05 | 24 |
| K772078 | Gelman Instrument Co. | RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN | 1978-02-03 | 92 |
Recalls for DAB devices
openFDA lists no recalls for product code DAB.
Frequently asked questions
What is FDA product code DAB?
DAB is the FDA product code for haptoglobin, fitc, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5460 and reviewed by the Immunology panel.
What device class is DAB?
Class II, regulation 21 CFR 866.5460. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DAB?
Across 3 cleared submissions the average was 76 days from receipt to decision (median 92).
Which companies have the most DAB clearances?
The Binding Site, Ltd. (1); Intl. Diagnostic Technology (1); Gelman Instrument Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DAB
- Run a recall and safety report across every DAB manufacturer
- Watch product code DAB 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.
All Immunology product codes · FDA product code lookup · 510(k) database search · 510(k) review times