PMA P120007S025
- Device
- Aptima HPV 16 18/45 Genotype Assay
- Applicant
- Gen-Probe Incorporated
- Product code
- OYB
- Decision date
- 2020-04-27
- Generic name
- Kit, rna detection, human papillomavirus
- Approval order statement
- Approval for the use of ThinPrep 5000 post-processed samples on the Aptima HPV 16 18/45 Genotype assay.
Current openFDA PMA Record#
- Device
- Aptima HPV 16 18/45 Genotype Assay
- Applicant
- Gen-Probe Incorporated
- PMA number
- P120007
- Supplement
- S025
- Product code
- OYB
- Generic name
- Kit, rna detection, human papillomavirus
- Decision date
- 2020-04-27
- Decision code
- APPR
- Date received
- 2019-11-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the use of ThinPrep 5000 post-processed samples on the Aptima HPV 16 18/45 Genotype assay.