PMA P120007
- Device
- Aptima HPV 16 18/45 Genotype Assay
- Applicant
- Gen-Probe Incorporated
- PMA number
- P120007
- Supplement
- S029
- Product code
- OYB
- Decision date
- 2026-02-03
- Generic name
- Kit, rna detection, human papillomavirus
- Approval order statement
- Approval for the Aptima HPV 16 18/45 Genotype Assay for expanding the indications to include primary screening.
Current openFDA PMA Record#
- Device
- Aptima HPV 16 18/45 Genotype Assay
- Applicant
- Gen-Probe Incorporated
- PMA number
- P120007
- Supplement
- S034
- Product code
- OYB
- Generic name
- Kit, rna detection, human papillomavirus
- Decision date
- 2026-02-03
- Decision code
- APPR
- Date received
- 2025-09-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the Aptima HPV 16 18/45 Genotype Assay for expanding the indications to include primary screening.