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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 HPV DNA ASSAY
Classification Namekit, dna detection, human papillomavirus
Generic Namehuman papillomavirus dna typing kit
ApplicantDIGENE DIAGNOSTICS, INC.
PMA NumberP890064
Supplement NumberS004
Date Received05/03/1996
Decision Date08/28/1996
Product Code
MAQ[ Registered Establishments with MAQ ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in manufacturing methods and procedures, and labeling modifications.
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