PMA P100042S010
- Device
- APTIMA HPV ASSAY
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100042
- Supplement
- S010
- Product code
- OYB
- Decision date
- 2016-05-20
- Classification
- Kit, Rna Detection, Human Papillomavirus
- Generic name
- Kit, rna detection, human papillomavirus
- Approval order statement
- Addition of a new manufacturing site, scale-up, cleaning process, and automated filling for reagent production.
Current openFDA PMA Record#
- Device
- APTIMA HPV ASSAY
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100042
- Supplement
- S010
- Product code
- OYB
- Generic name
- Kit, rna detection, human papillomavirus
- Decision date
- 2016-05-20
- Decision code
- OK30
- Date received
- 2016-04-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new manufacturing site, scale-up, cleaning process, and automated filling for reagent production.