DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 HPV DNA TEST
FDA premarket approval P890064/S018 · decided 2006-04-28
Approval details
- PMA number
- P890064
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 HPV DNA TEST
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen Gaithersburg, Inc.
- Date received
- 2006-03-24
- Decision date
- 2006-04-28
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR A CHANGE IN THE SAMPLE CONVERSION PROTOCOL FOR SPECIMENS COLLECTED IN PRESERVCYT SOLUTION. THE MAXIMUM NUMBER OF SPECIMENS THAT CAN BE PROCESSED AT ONE TIME WAS INCREASED FROM 20 TO 36 SPECIMENS.
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