FDA product code GPS: Antigen, Cf, Q Fever
GPS is the FDA product code for antigen, cf, q fever. It is a Class I device, regulated under 21 CFR 866.3500 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GPS. The average 510(k) review took 325 days (median 325).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Cf, Q Fever |
| Device class | Class I |
| Regulation | 21 CFR 866.3500 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GPS clearance
Top GPS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Institute Virion , Ltd. | 1 | 1985-08-08 |
Most recent GPS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K843672 | Institute Virion , Ltd. | Q-FEVER | 1985-08-08 | 325 |
Recalls for GPS devices
openFDA lists no recalls for product code GPS.
Frequently asked questions
What is FDA product code GPS?
GPS is the FDA product code for antigen, cf, q fever. It is a Class I device, regulated under 21 CFR 866.3500 and reviewed by the Microbiology panel.
What device class is GPS?
Class I, regulation 21 CFR 866.3500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GPS?
Across 1 cleared submissions the average was 325 days from receipt to decision (median 325).
Which companies have the most GPS clearances?
Institute Virion , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GPS
- Run a recall and safety report across every GPS manufacturer
- Watch product code GPS 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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