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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 NameHYBRID CAPTURE(TM) SYSTEM VIRATYPE(R) PLUS HPV DNA
Classification Namekit, dna detection, human papillomavirus
Generic Namehuman papillomavirus dna typing kit
ApplicantDIGENE DIAGNOSTICS, INC.
PMA NumberP890064
Supplement NumberS003
Date Received09/27/1993
Decision Date04/28/1995
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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