PMA P100042S030
- Device
- Aptima HPV Assay
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100042
- Supplement
- S030
- Product code
- OYB
- Decision date
- 2020-06-11
- Generic name
- Kit, rna detection, human papillomavirus
- Approval order statement
- Scale-up of reagents.
Current openFDA PMA Record#
- Device
- Aptima HPV Assay
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100042
- Supplement
- S030
- Product code
- OYB
- Generic name
- Kit, rna detection, human papillomavirus
- Decision date
- 2020-06-11
- Decision code
- OK30
- Date received
- 2020-05-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Scale-up of reagents.