FDA product code MDT: Elisa, Trichinella Spiralis
MDT is the FDA product code for elisa, trichinella spiralis. It is a Class I device, regulated under 21 CFR 866.3850 and reviewed by the Microbiology panel. Devices under MDT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for MDT devices.
Classification
| Field | Value |
|---|---|
| Device name | Elisa, Trichinella Spiralis |
| Device class | Class I |
| Regulation | 21 CFR 866.3850 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for MDT devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-04-22.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code MDT?
MDT is the FDA product code for elisa, trichinella spiralis. It is a Class I device, regulated under 21 CFR 866.3850 and reviewed by the Microbiology panel.
What device class is MDT?
Class I, regulation 21 CFR 866.3850. Typical premarket route: 510(k) exempt.
Have MDT devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2020-04-22.
Next steps
- Run an FDA pathway report with predicate devices for product code MDT
- Run a recall and safety report across every MDT manufacturer
- Watch product code MDT 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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