FDA product code NUL: For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System
NUL is the FDA product code for for export only - antigen, anti-skeletal, indirect fluorescent antibody test system. It is a Not classified device, reviewed by the Clinical Chemistry panel. Devices under NUL reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System |
| Device class | Not classified |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for NUL devices
openFDA lists no recalls for product code NUL.
Frequently asked questions
What is FDA product code NUL?
NUL is the FDA product code for for export only - antigen, anti-skeletal, indirect fluorescent antibody test system. It is a Not classified device, reviewed by the Clinical Chemistry panel.
What device class is NUL?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code NUL
- Run a recall and safety report across every NUL manufacturer
- Watch product code NUL 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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