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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.
 
DeviceQUANTIFERON - TB GOLD AND TB GOLD IN-TUBE
Generic Nametest, immunity, cell mediated, mycobacterium tuberculosis
Applicant
QIAGEN
19300 germantown road
germantown, MD 20874
PMA NumberP010033
Supplement NumberS014
Date Received06/02/2009
Decision Date01/29/2010
Product Code NCD 
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE USE OF THE DRY ROOM AT SCANTIBODIES LABORATORY, INC., SANTEE, CALIFORNIA, TO BE USED AS AN ALTERNATIVE METHOD TO VACUUM DRYING IN THE MANUFACTURING PROCESS OF ELISA PLATES.
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