PMA P160045S005
- Device
- Oncomine Dx Target
- Applicant
- Life Technologies Corporation
- PMA number
- P160045
- Supplement
- S005
- Product code
- PQP
- Decision date
- 2018-09-06
- Classification
- Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- Approval for final updated labeling for the software change from Torrent Suite Dx version 5.6.4 to version 5.8.
Current openFDA PMA Record#
- Device
- Oncomine Dx Target
- Applicant
- Life Technologies Corporation
- PMA number
- P160045
- Supplement
- S005
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2018-09-06
- Decision code
- APPR
- Date received
- 2018-03-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for final updated labeling for the software change from Torrent Suite Dx version 5.6.4 to version 5.8.