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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 NameDIGENE HYBRID CAPTURE II HIGH-RISK HPV DNA TEST
Classification Namekit, dna detection, human papillomavirus
Generic Namehuman papillomavirus dna detection kit
ApplicantDIGENE DIAGNOSTICS, INC.
PMA NumberP890064
Supplement NumberS007
Date Received02/07/2000
Decision Date03/16/2000
Product Code
MAQ[ Registered Establishments with MAQ ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for removal of the reagent component "probe a" and indication number 1. The device, as modified, will be marketed under the trade name digene high-risk hpv dna test using hybrid capture.
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