PMA P100042S003
- Device
- APTIMA HPV ASSAY
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100042
- Supplement
- S003
- Product code
- OYB
- Decision date
- 2014-07-07
- Classification
- Kit, Rna Detection, Human Papillomavirus
- Generic name
- Kit, rna detection, human papillomavirus
- Approval order statement
- CHANGE TO REVISE AN INTERNAL CONTROL QC RELEASE TEST SPECIFICATION FOR THE APTIMA® HPV ASSAY.
Current openFDA PMA Record#
- Device
- APTIMA HPV ASSAY
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100042
- Supplement
- S003
- Product code
- OYB
- Generic name
- Kit, rna detection, human papillomavirus
- Decision date
- 2014-07-07
- Decision code
- OK30
- Date received
- 2014-06-09
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE TO REVISE AN INTERNAL CONTROL QC RELEASE TEST SPECIFICATION FOR THE APTIMA® HPV ASSAY.