DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE CAPTURE 2 (HC2) HIGH HPV DNA TEST
FDA premarket approval P890064/S026 · decided 2011-04-20
Approval details
- PMA number
- P890064
- Supplement
- S026
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE CAPTURE 2 (HC2) HIGH HPV DNA TEST
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen Gaithersburg, Inc.
- Date received
- 2011-02-28
- Decision date
- 2011-04-20
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR SOFTWARE DESIGN CHANGE OF THE HC2 SYSTEM SUITE CONSISTING OF AN HC2 SYSTEM SOFTWARE UPGRADE FROM VERSION 2.0 TO VERSION 3.0.
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