|
Device | Oncomine Dx Target |
Generic Name | Next generation sequencing oncology panel, somatic or germline variant detection system |
Applicant | LIFE TECHNOLOGIES CORPORATION 5781 VAN ALLEN WAY CARLSBAD, CA 92008 |
PMA Number | P160045 |
Supplement Number | S005 |
Date Received | 03/22/2018 |
Decision Date | 09/06/2018 |
Product Code |
PQP |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for final updated labeling for the software change from Torrent Suite Dx version 5.6.4 to version 5.8. |