- Device
- Aptima HPV 16 18/45 Genotype Assay
- Applicant
- Gen-Probe Incorporated
- PMA number
- P120007
- Supplement
- S030
- Product code
- OYB
- Generic name
- Kit, rna detection, human papillomavirus
- Decision date
- 2023-06-02
- Decision code
- APPR
- Date received
- 2022-03-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of manual post-cytology (cytology by ThinPrep Genesis Processor) aliquot, pre-cytology aliquot and post-cytology (cytology by ThinPrep Genesis Processor) aliquot removed by the ThinPrep Genesis Processor as acceptable samples for the Aptima HPV Assay and Aptima HPV 16 18/45 Genotype Assay.