DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST
FDA premarket approval P890064/S014 · decided 2004-05-04
Approval details
- PMA number
- P890064
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen Gaithersburg, Inc.
- Date received
- 2003-11-05
- Decision date
- 2004-05-04
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL TO INCLUDE THE OPTIONAL USE OF AN AUTOMATED, HIGH-THROUGHPUT ROBOTIC PIPETTING AND MICROPLATE HANDLING SYSTEM KNOWN AS THE DIGENE RAPID CAPTURE SYSTEM (RCS).
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