QFO
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Zika Virus Serological Reagents
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3935
- Medical specialty
- Microbiology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader (K200506) | Chembio Diagnostic Systems | 2020-06-03 |
| LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set (K192046) | DiaSorin, Inc. | 2019-10-28 |
| ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control (K191578) | Siemens Healthcare Diagnostics, Inc. | 2019-07-17 |
| ZIKV Detect 2.0 IgM Capture ELISA (DEN180069) | InBios International, Inc. | 2019-05-23 |
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Every clearance here is in the API, with alerts when new ones post.