PMA P100042S033
- Device
- Aptima HPV Assay
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100042
- Supplement
- S033
- Product code
- OYB
- Decision date
- 2022-01-28
- Generic name
- Kit, rna detection, human papillomavirus
- Approval order statement
- Relocate manufacturing processes from one facility to another.
Current openFDA PMA Record#
- Device
- Aptima HPV Assay
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100042
- Supplement
- S033
- Product code
- OYB
- Generic name
- Kit, rna detection, human papillomavirus
- Decision date
- 2022-01-28
- Decision code
- OK30
- Date received
- 2022-01-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocate manufacturing processes from one facility to another.