FDA product code MIV: Immunofluorescent Assay, T. Cruzi
MIV is the FDA product code for immunofluorescent assay, t. cruzi. It is a Class I device, regulated under 21 CFR 866.3870 and reviewed by the Microbiology panel. Devices under MIV reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Immunofluorescent Assay, T. Cruzi |
| Device class | Class I |
| Regulation | 21 CFR 866.3870 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for MIV devices
openFDA lists no recalls for product code MIV.
Frequently asked questions
What is FDA product code MIV?
MIV is the FDA product code for immunofluorescent assay, t. cruzi. It is a Class I device, regulated under 21 CFR 866.3870 and reviewed by the Microbiology panel.
What device class is MIV?
Class I, regulation 21 CFR 866.3870. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MIV
- Run a recall and safety report across every MIV manufacturer
- Watch product code MIV 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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