FDA product code POA: Reagents, Zika Virus Nucleic Acid
POA is the FDA product code for reagents, zika virus nucleic acid. It is a Not classified device, reviewed by the Microbiology panel. Devices under POA reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for POA devices.
Definition
Nucleic acid-based in vitro diagnostic devices for the detection of Zika virus and diagnosis of Zika virus infection in human clinical specimens.
Classification
| Field | Value |
|---|---|
| Device name | Reagents, Zika Virus Nucleic Acid |
| Device class | Not classified |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for POA devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-11-16.
Frequently asked questions
What is FDA product code POA?
POA is the FDA product code for reagents, zika virus nucleic acid. It is a Not classified device, reviewed by the Microbiology panel.
What device class is POA?
Not classified. Typical premarket route: PMA.
Have POA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-11-16.
Next steps
- Run an FDA pathway report with predicate devices for product code POA
- Run a recall and safety report across every POA manufacturer
- Watch product code POA 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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