PMA P120007S026

Device: Aptima HPV 16 18/45 Genotype Assay
Applicant: Gen-Probe Incorporated
PMA number: P120007
Supplement: S026
Product code: OYB
Decision date: 2020-01-21
Generic name: Kit, rna detection, human papillomavirus
Approval order statement: Approval to add an alternate cleaning method for the Sample Shields and Target Capture Reagent (TCR) adapters used on the Panther/Panther Fusion instruments.

Current openFDA PMA Record#

Device: Aptima HPV 16 18/45 Genotype Assay
Applicant: Gen-Probe Incorporated
PMA number: P120007
Supplement: S026
Product code: OYB
Generic name: Kit, rna detection, human papillomavirus
Decision date: 2020-01-21
Decision code: APPR
Date received: 2019-12-23
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to add an alternate cleaning method for the Sample Shields and Target Capture Reagent (TCR) adapters used on the Panther/Panther Fusion instruments.