FDA product code KIX: Media, Mycoplasma Detection
KIX is the FDA product code for media, mycoplasma detection. It is a Class I device, regulated under 21 CFR 864.2360 and reviewed by the Pathology panel. Devices under KIX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Media, Mycoplasma Detection |
| Device class | Class I |
| Regulation | 21 CFR 864.2360 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Recalls for KIX devices
openFDA lists no recalls for product code KIX.
Frequently asked questions
What is FDA product code KIX?
KIX is the FDA product code for media, mycoplasma detection. It is a Class I device, regulated under 21 CFR 864.2360 and reviewed by the Pathology panel.
What device class is KIX?
Class I, regulation 21 CFR 864.2360. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KIX
- Run a recall and safety report across every KIX manufacturer
- Watch product code KIX 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.