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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 CAPTURE2
Classification Namekit, dna detection, human papillomavirus
Generic Namehuman papillomavirus dna detection kit
ApplicantQIAGEN GAITHERSBURG, INC
PMA NumberP890064
Supplement NumberS020
Date Received01/29/2008
Decision Date08/12/2009
Product Code
MAQ[ Registered Establishments with MAQ ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track no user fee
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at turner biosystems in sunnyvale, california, to manufacture the dml 3000¿ microplate luminometer which is intended for use with the hybrid capture 2 high risk hpv dna test and hybrid capture 2 hpv dna test.
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