FDA product code NUK: For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System
NUK is the FDA product code for for export only - antigen, anti-cardiac, indirect fluorescent antibody test system. It is a Not classified device, reviewed by the Clinical Chemistry panel. Devices under NUK reach the market by Contact FDA; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for NUK devices.
Classification
| Field | Value |
|---|---|
| Device name | For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System |
| Device class | Not classified |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for NUK devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-07-15.
Frequently asked questions
What is FDA product code NUK?
NUK is the FDA product code for for export only - antigen, anti-cardiac, indirect fluorescent antibody test system. It is a Not classified device, reviewed by the Clinical Chemistry panel.
What device class is NUK?
Not classified. Typical premarket route: Contact FDA.
Have NUK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-07-15.
Next steps
- Run an FDA pathway report with predicate devices for product code NUK
- Run a recall and safety report across every NUK manufacturer
- Watch product code NUK 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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