PMA P160023S015

Device: Aptima HCV Quant Dx Assay
Applicant: Hologic, Inc.
PMA number: P160023
Supplement: S015
Product code: MZP
Decision date: 2019-12-16
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
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 HCV Quant Dx Assay
Applicant: Hologic, Inc.
PMA number: P160023
Supplement: S015
Product code: MZP
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
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.