Zika Virus Serological Reagents
Microbiology · 21 CFR 866.3935
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 MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
8 firms currently registered for this product code
Siemens Healthcare Diagnostics Inc.
E Walpole, MA, US
Diasorin Inc.
Stillwater, MN, US
Chembio Diagnostic Systems, Inc.
MEDFORD, NY, US
Chembio Diagnostic Systems
Bay Shore, NY, US
Epitope Diagnostics, Inc.
SAN DIEGO, CA, US
Inbios International, Inc.
Seattle, WA, US
Roche Molecular Systems, Inc.
Branchburg, NJ, US
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
510(k) clearances
4 clearances for this product code
- Chembio Diagnostic SystemsJun 3, 2020
K200506 · DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
- DiaSorin, Inc.Oct 28, 2019
K192046 · LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
- Siemens Healthcare Diagnostics, Inc.Jul 17, 2019
K191578 · 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
- InBios International, Inc.May 23, 2019
DEN180069 · ZIKV Detect 2.0 IgM Capture ELISA