FDA product code PYS: Zika Virus Serological Reagents (Emergency Use)
PYS is the FDA product code for zika virus serological reagents (emergency use). It is a Not classified device, reviewed by the Microbiology panel. Devices under PYS reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The device aids in the presumptive clinical diagnosis of Zika virus infection in conjunction with other clinical and laboratory findings.
Classification
| Field | Value |
|---|---|
| Device name | Zika Virus Serological Reagents (Emergency Use) |
| Device class | Not classified |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for PYS devices
openFDA lists no recalls for product code PYS.
Frequently asked questions
What is FDA product code PYS?
PYS is the FDA product code for zika virus serological reagents (emergency use). It is a Not classified device, reviewed by the Microbiology panel.
What device class is PYS?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code PYS
- Run a recall and safety report across every PYS manufacturer
- Watch product code PYS 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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