- Device
- Oncomine™ Dx Target Test
- Applicant
- Life Technologies Corporation
- PMA number
- P160045
- Supplement
- S052
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2026-03-04
- Decision code
- APPR
- Date received
- 2026-01-20
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for an increase in quality control sampling of components during the QC release process