510(k) K191578
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2019
- Date Received
- June 14, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Zika Virus Serological Reagents
- Device Class
- Class II
- Regulation Number
- 866.3935
- Review Panel
- MI
- Submission Type
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.