HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY
FDA premarket approval P890064/S004 · decided 1996-08-28
Approval details
- PMA number
- P890064
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen Gaithersburg, Inc.
- Date received
- 1996-05-03
- Decision date
- 1996-08-28
- Days to decision
- 117 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR CHANGES IN MANUFACTURING METHODS AND PROCEDURES, AND LABELING MODIFICATIONS
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