PMA P100042S022
- Device
- APTIMA HPV Assay
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100042
- Supplement
- S022
- Product code
- OYB
- Decision date
- 2019-04-28
- Classification
- Kit, Rna Detection, Human Papillomavirus
- Generic name
- Kit, rna detection, human papillomavirus
- Approval order statement
- Approval for an alternate cleaning recommendation for the sample racks used on the Panther and Tigris instruments.
Current openFDA PMA Record#
- Device
- APTIMA HPV Assay
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100042
- Supplement
- S022
- Product code
- OYB
- Generic name
- Kit, rna detection, human papillomavirus
- Decision date
- 2019-04-28
- Decision code
- APPR
- Date received
- 2019-03-18
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an alternate cleaning recommendation for the sample racks used on the Panther and Tigris instruments.