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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 NumberS005
Date Received11/01/1996
Decision Date08/15/1997
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
Approval Order Statement 
Approval for use of a cervical broom specimen collected and transported in the cytyc corporation preservcyt(r) solution for testing in the digene corporation hybrid capture(tm) system hpv dna assay.
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