FDA product code GPN: Antiserum, Typhus Fever
GPN is the FDA product code for antiserum, typhus 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 GPN. The average 510(k) review took 142 days (median 142). FDA has posted 1 recall for GPN devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Typhus Fever |
| Device class | Class I |
| Regulation | 21 CFR 866.3500 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Top GPN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hillcrest Biologicals | 1 | 1987-03-12 |
Most recent GPN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K864110 | Hillcrest Biologicals | RICKETTSIAL IGG AND IGM IFA KIT | 1987-03-12 | 142 |
Recalls for GPN devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-22.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code GPN?
GPN is the FDA product code for antiserum, typhus fever. It is a Class I device, regulated under 21 CFR 866.3500 and reviewed by the Microbiology panel.
What device class is GPN?
Class I, regulation 21 CFR 866.3500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GPN?
Across 1 cleared submissions the average was 142 days from receipt to decision (median 142).
Which companies have the most GPN clearances?
Hillcrest Biologicals (1).
Have GPN devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-11-22.
Next steps
- Run an FDA pathway report with predicate devices for product code GPN
- Run a recall and safety report across every GPN manufacturer
- Watch product code GPN 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.