PYS — Zika Virus Serological Reagents (Emergency Use) Class N
FDA product code PYS covers "Zika Virus Serological Reagents (Emergency Use)", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PYS
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Unknown
- Implant
- No
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.