PMA P120007S029

Device: Aptima HPV 16 18/45 Genotype Assay
Applicant: Gen-Probe Incorporated
PMA number: P120007
Supplement: S029
Product code: OYB
Decision date: 2022-02-25
Generic name: Kit, rna detection, human papillomavirus
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 HPV 16 18/45 Genotype Assay
Applicant: Gen-Probe Incorporated
PMA number: P120007
Supplement: S029
Product code: OYB
Generic name: Kit, rna detection, human papillomavirus
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.