PMA P120007S008
- Device
- APTIMA HPV 16 18/45 GENOTYPE ASSAY
- Applicant
- Gen-Probe Incorporated
- PMA number
- P120007
- Supplement
- S008
- Product code
- OYB
- Decision date
- 2016-03-28
- Classification
- Kit, Rna Detection, Human Papillomavirus
- Generic name
- Kit, rna detection, human papillomavirus
- Approval order statement
- Scale up of the manufacturing process for three solutions used in the Aptima HPV 16 18/45 Genotype assay.
Current openFDA PMA Record#
- Device
- APTIMA HPV 16 18/45 GENOTYPE ASSAY
- Applicant
- Gen-Probe Incorporated
- PMA number
- P120007
- Supplement
- S008
- Product code
- OYB
- Generic name
- Kit, rna detection, human papillomavirus
- Decision date
- 2016-03-28
- Decision code
- OK30
- Date received
- 2016-03-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Scale up of the manufacturing process for three solutions used in the Aptima HPV 16 18/45 Genotype assay.