PMA P240040
- Device
- Oncomine Dx Express Test
- Applicant
- Life Technologies Corporation
- PMA number
- P240040
- Supplement
- S003
- Product code
- PQP
- Decision date
- 2025-10-22
- Classification
- Pathology
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- approval for manufacturing process changes
Current openFDA PMA Record#
- Device
- Oncomine Dx Express Test
- Applicant
- Life Technologies Corporation
- PMA number
- P240040
- Supplement
- S003
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2025-10-22
- Decision code
- OK30
- Date received
- 2025-09-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for manufacturing process changes