PMA P120007S011

Device: Aptima HPV 16 18/45 Genotype Assay
Applicant: Gen-Probe Incorporated
PMA number: P120007
Supplement: S011
Product code: OYB
Decision date: 2018-02-23
Classification: Kit, Rna Detection, Human Papillomavirus
Generic name: Kit, rna detection, human papillomavirus
Approval order statement: Approval for the use of the Aptima HPV 16 18/45 Genotype Assay on Panther Systems equipped with a Panther Fusion Module. The changes required for addition of the Panther Fusion Module that are subject to this approval include reconfiguration of the Panther System hardware, and updates to the Panther System and Aptima HPV 16 18/45 Genotype Assay software.

Current openFDA PMA Record#

Device: Aptima HPV 16 18/45 Genotype Assay
Applicant: Gen-Probe Incorporated
PMA number: P120007
Supplement: S011
Product code: OYB
Generic name: Kit, rna detection, human papillomavirus
Decision date: 2018-02-23
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 16 18/45 Genotype Assay on Panther Systems equipped with a Panther Fusion Module. The changes required for addition of the Panther Fusion Module that are subject to this approval include reconfiguration of the Panther System hardware, and updates to the Panther System and Aptima HPV 16 18/45 Genotype Assay software.