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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDIGENE HYBRID CAPTURE2
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantQiagen Gaithersburg, Inc.
19300 Germantown Rd.
Germantown, MD 20874
PMA NumberP890064
Supplement NumberS020
Date Received01/29/2008
Decision Date08/12/2009
Product Code MAQ 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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