Definition: An In Vitro Nucleic Acid Amplification Test That Measures The Concentration Of Prostate Cancer Genes.
| Device Type ID | 3140 |
| Device Name | Prostrate Cancer Genes Nucleic Acid Amplification Test System |
| Physical State | Capture Oligonucleotides, Magnetic Microparticles, Transcription-based Nucleic Acid Amplification Reagents, Chemiluminescent-labeled Nucleic Acid Probes. Luminometer, Software |
| Technical Method | Utilizes Nucleic Acid Probes And/or Primers Along With Other Reagents To Detect Prostrate Cancer Genes RNA From Human Specimens. |
| Target Area | Currently This Type Of Device Is Only Utilized On Urine Specimens, But Other Specimen Types May Be Possible. |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OYM |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |