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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameVIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT
Classification Namekit, dna detection, human papillomavirus
ApplicantMOLECULAR DIAGNOSTICS
PMA NumberP880009
Supplement NumberS003
Date Received09/18/1989
Decision Date02/01/1990
Product Code
MAQ[ Registered Establishments with MAQ ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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