CERVISTA HPV HR AND DNA EXTENSION KIT
FDA premarket approval P080014/S003 · decided 2010-10-06
Approval details
- PMA number
- P080014
- Supplement
- S003
- Supplement type
- Real-Time Process
- Trade name
- CERVISTA HPV HR AND DNA EXTENSION KIT
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Hologic, Inc.
- Date received
- 2010-09-16
- Decision date
- 2010-10-06
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- APPROVAL FOR SEVERAL CHANGES TO THE INVADER CALL REPORTER AND CERVISTA HPV HR SOFTWARE ON THE SEPARATE CDS WITH NEW PART NUMBERS.
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