Definition: In Vitro Qualitative Detection Of Non-variola Orthopoxvirus Nucleic Acids Extracted From Human Specimens Or Viral Culture.
| Device Type ID | 3554 |
| Device Name | Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set |
| Physical State | Provided In The Device Are Non-variola Orthopoxvirus Real-time PCR Assay Reagents Which Include Primers And Probes, Positive Controls, And An Extraction Control. |
| Technical Method | A Non-variola Orthopoxvirus Real-time PCR Assay Method Which Includes Nucleic Acid Isolation, Amplification And Detection Of Nucleic Acid Using A PCR Instrument. A Set Of Primers And Probes Are Used For The In Vitro Detection Of Non-variola Orthopoxv |
| Target Area | Human Clinical Samples (e.g., Pustular Or Vesicular Rash Specimens) And Viral Cell Culture Lysates |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3315 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PBK |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3554 |
| Device | Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set |
| Product Code | PBK |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 866.3315 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CENTERS FOR DISEASE CONTROL AND PREVENTION | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |
U.S. GOVERNMENT DEPARTMENT HHS | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |