HYBRID CAPTURE(TM) SYSTEM VIRATYPE(R) PLUS HPV DNA
FDA premarket approval P890064/S003 · decided 1995-04-28
Approval details
- PMA number
- P890064
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HYBRID CAPTURE(TM) SYSTEM VIRATYPE(R) PLUS HPV DNA
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen Gaithersburg, Inc.
- Date received
- 1993-09-27
- Decision date
- 1995-04-28
- Days to decision
- 578 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
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