PMA P160045S051
- Device
- Oncomine™ Dx Target Test
- Applicant
- Life Technologies Corporation
- PMA number
- P160045
- Supplement
- S051
- Product code
- PQP
- Decision date
- 2025-11-21
- Classification
- Pathology
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- approval of additional QC steps during the device component manufacturing process
Current openFDA PMA Record#
- Device
- Oncomine™ Dx Target Test
- Applicant
- Life Technologies Corporation
- PMA number
- P160045
- Supplement
- S051
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2025-11-21
- Decision code
- APPR
- Date received
- 2025-10-24
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of additional QC steps during the device component manufacturing process