- Device
- Oncomine Dx Target Test
- Applicant
- Life Technologies Corporation
- PMA number
- P160045
- Supplement
- S021
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2020-10-23
- Decision code
- APPR
- Date received
- 2020-07-27
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the expansion of shelf-life claim of the Oncomine Dx Target Test (ODxT Test) from 9 to 23 months.