FDA product code KFI: Strip, Virulence, Corynebacterium Diphtheriae
KFI is the FDA product code for strip, virulence, corynebacterium diphtheriae. It is a Class I device, regulated under 21 CFR 866.3140 and reviewed by the Microbiology panel. Devices under KFI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Strip, Virulence, Corynebacterium Diphtheriae |
| Device class | Class I |
| Regulation | 21 CFR 866.3140 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for KFI devices
openFDA lists no recalls for product code KFI.
Frequently asked questions
What is FDA product code KFI?
KFI is the FDA product code for strip, virulence, corynebacterium diphtheriae. It is a Class I device, regulated under 21 CFR 866.3140 and reviewed by the Microbiology panel.
What device class is KFI?
Class I, regulation 21 CFR 866.3140. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KFI
- Run a recall and safety report across every KFI manufacturer
- Watch product code KFI 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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