PMA P170025S017

Device: Aptima HBV Quant Assay
Applicant: Hologic, Inc.
PMA number: P170025
Supplement: S017
Product code: MKT
Decision date: 2022-02-25
Generic name: Hepatitis Viral B DNA Detection
Approval order statement: Approval to support the addition of the optional use of an automated dishwasher (Miele Dishwasher) to wash Panther Trax shuttle shields, sample racks, and storage racks used with the Aptima HPV assays.

Current openFDA PMA Record#

Device: Aptima HBV Quant Assay
Applicant: Hologic, Inc.
PMA number: P170025
Supplement: S017
Product code: MKT
Generic name: Hepatitis Viral B DNA Detection
Decision date: 2022-02-25
Decision code: APPR
Date received: 2021-12-14
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to support the addition of the optional use of an automated dishwasher (Miele Dishwasher) to wash Panther Trax shuttle shields, sample racks, and storage racks used with the Aptima HPV assays.