PMA P100042S026
- Device
- Aptima HPV Assay
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100042
- Supplement
- S026
- Product code
- OYB
- Decision date
- 2019-09-16
- Classification
- Kit, Rna Detection, Human Papillomavirus
- Generic name
- Kit, rna detection, human papillomavirus
- Approval order statement
- Increase the manufacturing scale for critical assay components.
Current openFDA PMA Record#
- Device
- Aptima HPV Assay
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100042
- Supplement
- S026
- Product code
- OYB
- Generic name
- Kit, rna detection, human papillomavirus
- Decision date
- 2019-09-16
- Decision code
- OK30
- Date received
- 2019-08-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Increase the manufacturing scale for critical assay components.