PMA P100042S036
- Device
- Aptima HPV Assay
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100042
- Supplement
- S036
- Product code
- OYB
- Decision date
- 2024-07-26
- Classification
- Microbiology
- Generic name
- Kit, rna detection, human papillomavirus
- Approval order statement
- a change in a QC test method
Current openFDA PMA Record#
- Device
- Aptima HPV Assay
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100042
- Supplement
- S036
- Product code
- OYB
- Generic name
- Kit, rna detection, human papillomavirus
- Decision date
- 2024-07-26
- Decision code
- OK30
- Date received
- 2024-06-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in a QC test method