QFO — Zika Virus Serological Reagents Class II
Classification Details
- Product Code
- QFO
- Device Class
- Class II
- Regulation Number
- 866.3935
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- 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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K200506 | chembio diagnostic systems | DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader | June 3, 2020 |
| K192046 | diasorin | LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set | October 28, 2019 |
| K191578 | siemens healthcare diagnostics | ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika I | July 17, 2019 |
| DEN180069 | inbios international | ZIKV Detect 2.0 IgM Capture ELISA | May 23, 2019 |