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 Epidemio
| Device Type ID | 3627 |
| Device Name | Zika Virus Serological Reagents (emergency Use) |
| Physical State | In Vitro Diagnostic Antigens And Antisera |
| Technical Method | Immunological Methods / ELISA |
| 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 |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | EUA - Emergency Use Authorizat |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | PYS |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |