Definition: Nucleic Acid-based In Vitro Diagnostic Devices For The Presumptive Detection And Identification Of Ebola Zaire Virus (detected In The West Africa Outbreak In 2014) In Human Clinical Specimens
| Device Type ID | 3625 |
| Device Name | Reagents, Ebola Zaire Virus (detected In The West Africa Outbreak In 2014) Nucleic Acid |
| Physical State | In Vitro Diagnostic Primers And Probes |
| 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 | POG |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |