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U.S. Department of Health and Human Services

Product Classification
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Device reagents, zika virus nucleic acid
Definition Nucleic acid-based in vitro diagnostic devices for the detection of Zika virus and diagnosis of Zika virus infection in human clinical specimens.
Physical State In Vitro Diagnostic Primers, Probes and/or capture oligonucleotides.
Technical Method Nucleic acid amplification.
Target Area The device is an in-vitro diagnostic device; none of the body parts will utilize the device or are intended to be affected by the device.
Review Panel Microbiology
Product CodePOA
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Not Classified Reason EUA - Emergency Use Authorization
Submission Type EUA - Emergency Use Authorization
Device Class Not Classified
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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