FDA product code GNH: Antigen, Fluorescent Antibody Test, Schistosoma Mansoni
GNH is the FDA product code for antigen, fluorescent antibody test, schistosoma mansoni. It is a Class I device, regulated under 21 CFR 866.3600 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under GNH. The average 510(k) review took 90 days (median 90).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Fluorescent Antibody Test, Schistosoma Mansoni |
| Device class | Class I |
| Regulation | 21 CFR 866.3600 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GNH clearance
Top GNH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Amico Lab, Inc. | 2 | 1984-10-30 |
Most recent GNH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842660 | Amico Lab, Inc. | ANTI-SCHISTOSOMA SPECIES KIT | 1984-10-30 | 112 |
| K842527 | Amico Lab, Inc. | AMIZYME-SCHISTOSOMA SPP. TEST KIT | 1984-09-05 | 69 |
Recalls for GNH devices
openFDA lists no recalls for product code GNH.
Frequently asked questions
What is FDA product code GNH?
GNH is the FDA product code for antigen, fluorescent antibody test, schistosoma mansoni. It is a Class I device, regulated under 21 CFR 866.3600 and reviewed by the Microbiology panel.
What device class is GNH?
Class I, regulation 21 CFR 866.3600. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GNH?
Across 2 cleared submissions the average was 90 days from receipt to decision (median 90).
Which companies have the most GNH clearances?
Amico Lab, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code GNH
- Run a recall and safety report across every GNH manufacturer
- Watch product code GNH 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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