- Device
- Oncomine Dx Target Test
- Applicant
- Life Technologies Corporation
- PMA number
- P160045
- Supplement
- S037
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2022-09-19
- Decision code
- APPR
- Date received
- 2022-06-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the revised DNA and RNA controls (DNA Control v3 and RNA Control v2) for the Oncomine Dx Target Test