PMA P120007S018
- Device
- Aptima HPV 16 18/45 Genotype Assay
- Applicant
- Gen-Probe Incorporated
- PMA number
- P120007
- Supplement
- S018
- Product code
- OYB
- Decision date
- 2019-02-28
- Classification
- Kit, Rna Detection, Human Papillomavirus
- Generic name
- Kit, rna detection, human papillomavirus
- Approval order statement
- Approval for an alternate cleaning method for the samples racks used on the Panther, Panther Fusion, and Tigris instruments.
Current openFDA PMA Record#
- Device
- Aptima HPV 16 18/45 Genotype Assay
- Applicant
- Gen-Probe Incorporated
- PMA number
- P120007
- Supplement
- S018
- Product code
- OYB
- Generic name
- Kit, rna detection, human papillomavirus
- Decision date
- 2019-02-28
- Decision code
- APPR
- Date received
- 2018-12-31
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an alternate cleaning method for the samples racks used on the Panther, Panther Fusion, and Tigris instruments.