FDA product code DAS: Igg (Fc Fragment Specific), Antigen, Antiserum, Control
DAS is the FDA product code for igg (fc fragment specific), antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5530 and reviewed by the Immunology panel. FDA has cleared 8 510(k) submissions under DAS, from 5 different applicants. The average 510(k) review took 77 days (median 72).
Classification
| Field | Value |
|---|---|
| Device name | Igg (Fc Fragment Specific), Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5530 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DAS clearance
Top DAS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Research Diagnostics, Inc. | 3 | 1994-12-15 |
| Kent Laboratories, Inc. | 2 | 1979-08-22 |
| Inova Diagnostics, Inc. | 1 | 1998-09-04 |
| The Binding Site, Ltd. | 1 | 1989-11-08 |
| Supelco, Inc. | 1 | 1976-12-09 |
Most recent DAS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K982023 | Inova Diagnostics, Inc. | PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT | 1998-09-04 | 87 |
| K944876 | Research Diagnostics, Inc. | HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT | 1994-12-15 | 73 |
| K943098 | Research Diagnostics, Inc. | HUMAN IGG SUBCLASSES ELISA COMBI KIT | 1994-09-07 | 71 |
| K943205 | Research Diagnostics, Inc. | HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) | 1994-09-07 | 64 |
| K895600 | The Binding Site, Ltd. | HUMAN (IGG) SUBCLASS (EIA) KIT | 1989-11-08 | 51 |
Recalls for DAS devices
openFDA lists no recalls for product code DAS.
Frequently asked questions
What is FDA product code DAS?
DAS is the FDA product code for igg (fc fragment specific), antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5530 and reviewed by the Immunology panel.
What device class is DAS?
Class I, regulation 21 CFR 866.5530. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DAS?
Across 8 cleared submissions the average was 77 days from receipt to decision (median 72).
Which companies have the most DAS clearances?
Research Diagnostics, Inc. (3); Kent Laboratories, Inc. (2); Inova Diagnostics, Inc. (1); The Binding Site, Ltd. (1); Supelco, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DAS
- Run a recall and safety report across every DAS manufacturer
- Watch product code DAS 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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