PMA P100042S013

Device: Aptima HPV Assay
Applicant: Gen-Probe Incorporated
PMA number: P100042
Supplement: S013
Product code: OYB
Decision date: 2018-02-28
Classification: Kit, Rna Detection, Human Papillomavirus
Generic name: Kit, rna detection, human papillomavirus
Approval order statement: Approval for the use of the Aptima HPV Assay on Panther Systems equipped with the Panther Fusion Module. The changes required for addition of the Panther Fusion Module that are subject of this approval include reconfiguration of the Panther system hardware and updates to the Panther System and Aptima HPV Assay software.

Current openFDA PMA Record#

Device: Aptima HPV Assay
Applicant: Gen-Probe Incorporated
PMA number: P100042
Supplement: S013
Product code: OYB
Generic name: Kit, rna detection, human papillomavirus
Decision date: 2018-02-28
Decision code: APPR
Date received: 2017-09-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the use of the Aptima HPV Assay on Panther Systems equipped with the Panther Fusion Module. The changes required for addition of the Panther Fusion Module that are subject of this approval include reconfiguration of the Panther system hardware and updates to the Panther System and Aptima HPV Assay software.