FDA product code MCG: Dna-Probe, Agent, Listeria
MCG is the FDA product code for dna-probe, agent, listeria. It is a Class I device, regulated under 21 CFR 866.3355 and reviewed by the Microbiology panel. Devices under MCG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Dna-Probe, Agent, Listeria |
| Device class | Class I |
| Regulation | 21 CFR 866.3355 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for MCG devices
openFDA lists no recalls for product code MCG.
Frequently asked questions
What is FDA product code MCG?
MCG is the FDA product code for dna-probe, agent, listeria. It is a Class I device, regulated under 21 CFR 866.3355 and reviewed by the Microbiology panel.
What device class is MCG?
Class I, regulation 21 CFR 866.3355. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code MCG
- Run a recall and safety report across every MCG manufacturer
- Watch product code MCG 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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