FDA product code NDV: Test, Ecarin Clotting Time (Ect)
NDV is the FDA product code for test, ecarin clotting time (ect). It is a HDE device, reviewed by the Hematology panel. Devices under NDV reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Test, Ecarin Clotting Time (Ect) |
| Device class | HDE |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
Recalls for NDV devices
openFDA lists no recalls for product code NDV.
Frequently asked questions
What is FDA product code NDV?
NDV is the FDA product code for test, ecarin clotting time (ect). It is a HDE device, reviewed by the Hematology panel.
What device class is NDV?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code NDV
- Run a recall and safety report across every NDV manufacturer
- Watch product code NDV 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.