PMA P120007S022

Device: Aptima HPV 16 18/45 Genotype Assay
Applicant: Gen-Probe Incorporated
Product code: OYB
Decision date: 2019-12-16
Generic name: Kit, rna detection, human papillomavirus
Approval order statement: Approval for the addition of a Multi-tube unit (MTU) sidecar, Continuous Fluids Module, Waste-to-Drain Module, and Shuttle Module to the Panther and Panther Fusion instruments.

Current openFDA PMA Record#

Device: Aptima HPV 16 18/45 Genotype Assay
Applicant: Gen-Probe Incorporated
PMA number: P120007
Supplement: S022
Product code: OYB
Generic name: Kit, rna detection, human papillomavirus
Decision date: 2019-12-16
Decision code: APPR
Date received: 2019-06-21
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the addition of a Multi-tube unit (MTU) sidecar, Continuous Fluids Module, Waste-to-Drain Module, and Shuttle Module to the Panther and Panther Fusion instruments.