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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 NameVIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT
Classification Namekit, dna detection, human papillomavirus
Generic Namehuman papillomavirus dna typing kit
ApplicantDIGENE DIAGNOSTICS, INC.
PMA NumberP890064
Supplement NumberS002
Date Received12/09/1992
Decision Date05/19/1994
Product Code
MAQ[ Registered Establishments with MAQ ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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