PMA P170025S001

Device: Aptima HBV Quant Assay
Applicant: Hologic, Inc.
PMA number: P170025
Supplement: S001
Product code: MKT
Decision date: 2018-10-02
Classification: Hepatitis Viral B Dna Detection
Generic name: Hepatitis Viral B DNA Detection
Approval order statement: Approval for the use of the Aptima HBV Quant Assay on the Panther System with the attachment of the Panther Fusion Module. The changes being approved include the addition of new hardware and updated software.

Current openFDA PMA Record#

Device: Aptima HBV Quant Assay
Applicant: Hologic, Inc.
PMA number: P170025
Supplement: S001
Product code: MKT
Generic name: Hepatitis Viral B DNA Detection
Decision date: 2018-10-02
Decision code: APPR
Date received: 2018-02-21
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the use of the Aptima HBV Quant Assay on the Panther System with the attachment of the Panther Fusion Module. The changes being approved include the addition of new hardware and updated software.