FDA product code POG: Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid
POG is the FDA product code for reagents, ebola zaire virus (detected in the west africa outbreak in 2014) nucleic acid. It is a Not classified device, reviewed by the Microbiology panel. Devices under POG reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Nucleic acid-based in vitro diagnostic devices for the presumptive detection and identification of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in human clinical specimens
Classification
| Field | Value |
|---|---|
| Device name | Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid |
| Device class | Not classified |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for POG devices
openFDA lists no recalls for product code POG.
Frequently asked questions
What is FDA product code POG?
POG is the FDA product code for reagents, ebola zaire virus (detected in the west africa outbreak in 2014) nucleic acid. It is a Not classified device, reviewed by the Microbiology panel.
What device class is POG?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code POG
- Run a recall and safety report across every POG manufacturer
- Watch product code POG 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.