VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT

Kit, Dna Detection, Human Papillomavirus

FDA Premarket Approval P880009 S004

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

• Device: VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT
• Classification Name: Kit, Dna Detection, Human Papillomavirus
• Generic Name: Kit, Dna Detection, Human Papillomavirus
• Applicant: QIAGEN, INC.
• Date Received: 1991-05-24
• Decision Date: 1991-08-19
• PMA: P880009
• Supplement: S004
• Product Code: MAQ
• Advisory Committee: Microbiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: QIAGEN, INC. 1201 Clopper Road gaithersburg, MD 20878

Supplemental Filings

Supplement Number	Date	Supplement Type
P880009		Original Filing
S005	1991-10-18	Normal 180 Day Track
S004	1991-05-24	Normal 180 Day Track
S003	1989-09-18	Normal 180 Day Track
S002	1989-06-16	Normal 180 Day Track
S001	1989-04-04	Normal 180 Day Track