PMA P120007S002
- Device
- APTIMA HPV 16 18/45 GENETYPE ASSAY
- Applicant
- Gen-Probe Incorporated
- PMA number
- P120007
- Supplement
- S002
- Product code
- OYB
- Decision date
- 2014-04-29
- Classification
- Kit, Rna Detection, Human Papillomavirus
- Generic name
- Kit, rna detection, human papillomavirus
- Approval order statement
- APPROVAL FOR THE MINOR SOFTWARE CHANGES FOR THE APTIMA HPV ASSAY SOFTWARE (V2.3.5), THE APTIMA HPV-GT ASSAY SOFTWARE (V2.7.5), PANTHER SYSTEM SOFTWARE (V5.2).
Current openFDA PMA Record#
- Device
- APTIMA HPV 16 18/45 GENETYPE ASSAY
- Applicant
- Gen-Probe Incorporated
- PMA number
- P120007
- Supplement
- S002
- Product code
- OYB
- Generic name
- Kit, rna detection, human papillomavirus
- Decision date
- 2014-04-29
- Decision code
- APPR
- Date received
- 2014-04-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MINOR SOFTWARE CHANGES FOR THE APTIMA HPV ASSAY SOFTWARE (V2.3.5), THE APTIMA HPV-GT ASSAY SOFTWARE (V2.7.5), PANTHER SYSTEM SOFTWARE (V5.2).