PMA P120007S032
- Device
- Aptima HPV-GT Assay
- Applicant
- Gen-Probe Incorporated
- PMA number
- P120007
- Supplement
- S032
- Product code
- OYB
- Decision date
- 2024-10-23
- Classification
- Microbiology
- Generic name
- Kit, rna detection, human papillomavirus
- Approval order statement
- a modification of a test method
Current openFDA PMA Record#
- Device
- Aptima HPV-GT Assay
- Applicant
- Gen-Probe Incorporated
- PMA number
- P120007
- Supplement
- S032
- Product code
- OYB
- Generic name
- Kit, rna detection, human papillomavirus
- Decision date
- 2024-10-23
- Decision code
- OK30
- Date received
- 2024-09-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a modification of a test method