PJG · Cancer-Related Germline Gene Mutation Detection System
· Class 3
Overview
| Product Code | PJG |
|---|---|
| Device Name | Cancer-Related Germline Gene Mutation Detection System |
| Device Class | Class 3 |
| Review Panel |
Identification
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P190014 | myChoice HRD CDx | Myriad Genetic Laboratories, Inc. | Oct 23, 2019 | APPR |
| P140020 | BRACANALYSIS CDX | Myriad Genetic Laboratories | Dec 19, 2014 | APPR |
Top Applicants
- Myriad Genetic Laboratories — 1 clearance
- Myriad Genetic Laboratories, Inc. — 1 clearance
