DIGENE HC2 SYSTEM SOFTWARE
FDA premarket approval P890064/S031 · decided 2014-10-09
Approval details
- PMA number
- P890064
- Supplement
- S031
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIGENE HC2 SYSTEM SOFTWARE
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen Gaithersburg, Inc.
- Date received
- 2014-09-23
- Decision date
- 2014-10-09
- Days to decision
- 16 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR THE UPGRADE OF THE HC2 SOFTWARE SUITE TO VERSION 4.3.
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