Cancer-related Germline Gene Mutation Detection System
Device Code: 5048
Product Code(s):
PJG Definition: The Germline Gene Mutation Test System Is An In Vitro Diagnostic Nucleic Acid Amplification And Detection System For The Identification Of Genetic Mutations In DNA Extracted From Human Clinical Specimens.
Device Classification Information
| Device Type ID | 5048 |
| Device Name | Cancer-related Germline Gene Mutation Detection System |
| Physical State | Test Consists Of Reagents, Instrumentation, Software And Instructions Needed To Perform The Test Method. |
| Technical Method | In Vitro Amplification And Detection Of Genomic DNA Representing A Cancer-related Germline Gene Mutation From A Clinical Specimen Of Interest |
| Target Area | Human Peripheral Whole Blood Or Clinical Samples |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PJG |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 5048 |
| Device | Cancer-related Germline Gene Mutation Detection System |
| Product Code | PJG |
| FDA Device Classification | Class 3 Medical Device |
TPLC Last Update: 2019-04-02 20:59:21