Definition: For The Detection Of Human Papillomavirus RNA To Aid In Assessing Risk Of Cancer.
| Device Type ID | 3621 |
| Device Name | Kit, Rna Detection, Human Papillomavirus |
| Physical State | Device Is Supplied As An In Vitro Diagnositc Kit Containing Various Reagents, Instructions For Use And Possibly Instrumentation And Software. |
| Technical Method | Utilizes Nucleic Acid Probes And/or Primers Along With Other Reagents To Detect Human Papillomavirus RNA Directly From Human Specimens |
| Target Area | Currently, This Type Of Device Is Only Utilized On Cervical Specimens, But Other Specimen Types Are Possible. |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OYB |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3621 |
| Device | Kit, Rna Detection, Human Papillomavirus |
| Product Code | OYB |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Output Problem | 2 |
Use Of Device Problem | 1 |
| Total Device Problems | 3 |