FDA product code NCD: Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
NCD is the FDA product code for test, immunity, cell mediated, mycobacterium tuberculosis. It is a Class III device, reviewed by the Microbiology panel. Devices under NCD reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 3 recalls for NCD devices.
Classification
| Field | Value |
|---|---|
| Device name | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis |
| Device class | Class III |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for NCD devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-02-02.
Frequently asked questions
What is FDA product code NCD?
NCD is the FDA product code for test, immunity, cell mediated, mycobacterium tuberculosis. It is a Class III device, reviewed by the Microbiology panel.
What device class is NCD?
Class III. Typical premarket route: PMA.
Have NCD devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2016-02-02.
Next steps
- Run an FDA pathway report with predicate devices for product code NCD
- Run a recall and safety report across every NCD manufacturer
- Watch product code NCD 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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