- Device
- Agilent Resolution ctDx FIRST
- Applicant
- Exact Sciences Corporation
- PMA number
- P210040
- Supplement
- S001
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2023-07-27
- Decision code
- APPR
- Date received
- 2023-06-27
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for modifications to the Instructions for Use for the Agilent Resolution Sample Collection Kit, a component of the Agilent Resolution ctDx FIRST assay