FDA product code CGT: Radioimmunoassay, Cyclic Gmp
CGT is the FDA product code for radioimmunoassay, cyclic gmp. It is a Class II device, regulated under 21 CFR 862.1230 and reviewed by the Clinical Chemistry panel. Devices under CGT reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Cyclic Gmp |
| Device class | Class II |
| Regulation | 21 CFR 862.1230 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for CGT devices
openFDA lists no recalls for product code CGT.
Frequently asked questions
What is FDA product code CGT?
CGT is the FDA product code for radioimmunoassay, cyclic gmp. It is a Class II device, regulated under 21 CFR 862.1230 and reviewed by the Clinical Chemistry panel.
What device class is CGT?
Class II, regulation 21 CFR 862.1230. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code CGT
- Run a recall and safety report across every CGT manufacturer
- Watch product code CGT 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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