FDA product code MJI: Specimen/Tissue, Identification Orientation
MJI is the FDA product code for specimen/tissue, identification orientation. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel. Devices under MJI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Specimen/Tissue, Identification Orientation |
| Device class | Class I |
| Regulation | 21 CFR 864.3010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for MJI devices
openFDA lists no recalls for product code MJI.
Frequently asked questions
What is FDA product code MJI?
MJI is the FDA product code for specimen/tissue, identification orientation. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is MJI?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code MJI
- Run a recall and safety report across every MJI manufacturer
- Watch product code MJI 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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