PMA P170025S013

Device: Aptima HBV Quant Assay
Applicant: Hologic, Inc.
PMA number: P170025
Supplement: S013
Product code: MKT
Decision date: 2019-12-16
Generic name: Hepatitis Viral B DNA Detection
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 HBV Quant Assay
Applicant: Hologic, Inc.
PMA number: P170025
Supplement: S013
Product code: MKT
Generic name: Hepatitis Viral B DNA Detection
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.