PMA P120007S010
- Device
- Aptima HPV 16 18/45 Genotype Assay.
- Applicant
- Gen-Probe Incorporated
- PMA number
- P120007
- Supplement
- S010
- Product code
- OYB
- Decision date
- 2017-05-04
- Classification
- Kit, Rna Detection, Human Papillomavirus
- Generic name
- Kit, rna detection, human papillomavirus
- Approval order statement
- Approval for minor design changes to the Tigris instrument and System software.
Current openFDA PMA Record#
- Device
- Aptima HPV 16 18/45 Genotype Assay.
- Applicant
- Gen-Probe Incorporated
- PMA number
- P120007
- Supplement
- S010
- Product code
- OYB
- Generic name
- Kit, rna detection, human papillomavirus
- Decision date
- 2017-05-04
- Decision code
- APPR
- Date received
- 2017-03-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor design changes to the Tigris instrument and System software.