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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 HPV DNA TEST
Classification Namekit, dna detection, human papillomavirus
Generic Namehuman papillomavirus dna detection kit
ApplicantDIGENE CORP.
PMA NumberP890064
Supplement NumberS015
Date Received05/28/2004
Decision Date07/29/2004
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 revisions to the assay's labeling performance characteristics section. The change involves moving the section "relative false-positive and false-negative rate" from the labeling's clinical performance section to the analytical section with narrative revisions. The new section is entitled "external study using clinical specimens. " a new note has been added to the current labeling's table 10 referenced to snijders, pjf, van de brule, ajc, and meijer, cjlm, "the clinical relevance of human papillomavirus testing: relationship between analytical and clinical sensitivity". J pathol 2003; 201: 1-6.
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