PMA P120007S006
- Device
- APTIMA HPV 16 18/45 GENOTYPE ASSAY
- Applicant
- Gen-Probe Incorporated
- PMA number
- P120007
- Supplement
- S006
- Product code
- OYB
- Decision date
- 2016-09-19
- Classification
- Kit, Rna Detection, Human Papillomavirus
- Generic name
- Kit, rna detection, human papillomavirus
- Approval order statement
- Approval for a change of a raw material supplier.
Current openFDA PMA Record#
- Device
- APTIMA HPV 16 18/45 GENOTYPE ASSAY
- Applicant
- Gen-Probe Incorporated
- PMA number
- P120007
- Supplement
- S006
- Product code
- OYB
- Generic name
- Kit, rna detection, human papillomavirus
- Decision date
- 2016-09-19
- Decision code
- APPR
- Date received
- 2015-08-28
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change of a raw material supplier.