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U.S. Department of Health and Human Services

Product Classification

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Device zika virus serological reagents
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.
Physical State In Vitro Diagnostic antigens and antisera; ELISA Kit including different components, i.e., ELISA plates coated with antibodies, other capture antibodies, positive and negative controls etc.
Technical Method Immunological methods e.g., ELISA
Target Area Human serum or plasma or whole blood or body fluid collected from patient; none of the body parts will utilize the device or are intended to be affected by the device.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQFO
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3935
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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