FDA product code GPT: Antiserum, Cf, Psittacosis (Chlamydia Group)
GPT is the FDA product code for antiserum, cf, psittacosis (chlamydia group). It is a Class I device, regulated under 21 CFR 866.3120 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GPT. The average 510(k) review took 36 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Cf, Psittacosis (Chlamydia Group) |
| Device class | Class I |
| Regulation | 21 CFR 866.3120 |
| 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 GPT clearance
Top GPT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bartels Immunodiagnostic Supplies, Inc. | 1 | 1981-05-05 |
Most recent GPT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K810856 | Bartels Immunodiagnostic Supplies, Inc. | DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT | 1981-05-05 | 36 |
Recalls for GPT devices
openFDA lists no recalls for product code GPT.
Frequently asked questions
What is FDA product code GPT?
GPT is the FDA product code for antiserum, cf, psittacosis (chlamydia group). It is a Class I device, regulated under 21 CFR 866.3120 and reviewed by the Microbiology panel.
What device class is GPT?
Class I, regulation 21 CFR 866.3120. Typical premarket route: 510(k).
How long does a 510(k) take for product code GPT?
Across 1 cleared submissions the average was 36 days from receipt to decision (median 36).
Which companies have the most GPT clearances?
Bartels Immunodiagnostic Supplies, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GPT
- Run a recall and safety report across every GPT manufacturer
- Watch product code GPT 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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