Definition: Nucleic Acid-based In Vitro Diagnostic Devices For The Detection Of Zika Virus And Diagnosis Of Zika Virus Infection In Human Clinical Specimens.
| Device Type ID | 3624 |
| Device Name | Reagents, Zika Virus Nucleic Acid |
| 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 |
| 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 | POA |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |