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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 2 HIGH-RISK HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 HPV DNA TEST
Classification Namekit, dna detection, human papillomavirus
Generic Namehuman papillomavirus dna detection kit
ApplicantDIGENE CORP.
PMA NumberP890064
Supplement NumberS018
Date Received03/28/2006
Decision Date04/28/2006
Product Code
MAQ[ Registered Establishments with MAQ ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the sample conversion protocol for specimens collected in preservcyt solution. The maximum number of specimens that can be processed at one time was increased from 20 to 36 specimens.
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