FDA product code SAD: Japanese Encephalitis Virus Immunological/Serology Test
SAD is the FDA product code for japanese encephalitis virus immunological/serology test. It is a Not classified device, reviewed by the Microbiology panel. Devices under SAD reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
Product code for export only
Classification
| Field | Value |
|---|---|
| Device name | Japanese Encephalitis Virus Immunological/Serology Test |
| Device class | Not classified |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for SAD devices
openFDA lists no recalls for product code SAD.
Frequently asked questions
What is FDA product code SAD?
SAD is the FDA product code for japanese encephalitis virus immunological/serology test. It is a Not classified device, reviewed by the Microbiology panel.
What device class is SAD?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code SAD
- Run a recall and safety report across every SAD manufacturer
- Watch product code SAD 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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