PMA P080014S003
- Device
- CERVISTA HPV HR AND DNA EXTENSION KIT
- Applicant
- Hologic, Inc.
- PMA number
- P080014
- Supplement
- S003
- Product code
- MAQ
- Decision date
- 2010-10-06
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- APPROVAL FOR SEVERAL CHANGES TO THE INVADER CALL REPORTER AND CERVISTA HPV HR SOFTWARE ON THE SEPARATE CDS WITH NEW PART NUMBERS.
Current openFDA PMA Record#
- Device
- CERVISTA HPV HR AND DNA EXTENSION KIT
- Applicant
- Hologic, Inc.
- PMA number
- P080014
- Supplement
- S003
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2010-10-06
- Decision code
- APPR
- Date received
- 2010-09-16
- Supplement type
- Real-Time Process
- Approval order statement
- APPROVAL FOR SEVERAL CHANGES TO THE INVADER CALL REPORTER AND CERVISTA HPV HR SOFTWARE ON THE SEPARATE CDS WITH NEW PART NUMBERS.