FDA product code MKA: Kit, Direct Antigen, Negative Control
MKA is the FDA product code for kit, direct antigen, negative control. It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Microbiology panel. Devices under MKA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Direct Antigen, Negative Control |
| Device class | Class I |
| Regulation | 21 CFR 862.1660 |
| Review panel | MI — Microbiology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for MKA devices
openFDA lists no recalls for product code MKA.
Frequently asked questions
What is FDA product code MKA?
MKA is the FDA product code for kit, direct antigen, negative control. It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Microbiology panel.
What device class is MKA?
Class I, regulation 21 CFR 862.1660. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code MKA
- Run a recall and safety report across every MKA manufacturer
- Watch product code MKA 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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