FDA product code GNE: Antigen, Latex Agglutination, T. Cruzi
GNE is the FDA product code for antigen, latex agglutination, t. cruzi. It is a Class I device, regulated under 21 CFR 866.3870 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GNE. The average 510(k) review took 84 days (median 84).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Latex Agglutination, T. Cruzi |
| Device class | Class I |
| Regulation | 21 CFR 866.3870 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GNE clearance
Top GNE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sero-Immuno Diagnostics, Inc. | 1 | 1984-03-02 |
Most recent GNE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K834328 | Sero-Immuno Diagnostics, Inc. | DAT TEST FOR CHAGAS' DISEASE | 1984-03-02 | 84 |
Recalls for GNE devices
openFDA lists no recalls for product code GNE.
Frequently asked questions
What is FDA product code GNE?
GNE is the FDA product code for antigen, latex agglutination, t. cruzi. It is a Class I device, regulated under 21 CFR 866.3870 and reviewed by the Microbiology panel.
What device class is GNE?
Class I, regulation 21 CFR 866.3870. Typical premarket route: 510(k).
How long does a 510(k) take for product code GNE?
Across 1 cleared submissions the average was 84 days from receipt to decision (median 84).
Which companies have the most GNE clearances?
Sero-Immuno Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GNE
- Run a recall and safety report across every GNE manufacturer
- Watch product code GNE 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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