|
Device | BRACAnalysis CDx |
Generic Name | Cancer-related germline gene mutation detection system |
Applicant | MYRIAD GENETIC LABORATORIES 320 Wakara Way Salt Lake City, UT 84108 |
PMA Number | P140020 |
Supplement Number | S017 |
Date Received | 07/31/2018 |
Decision Date | 10/25/2018 |
Product Code |
PJG |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to reduce the number of samples for PQ for like-for-like instruments replacement |