PMA P160045

Device: Oncomine™ Dx Target Test
Applicant: Life Technologies Corporation
PMA number: P160045
Supplement: S038
Product code: PQP
Decision date: 2026-03-04
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: approval for an increase in quality control sampling of components during the QC release process

Current openFDA PMA Record#

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