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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.
 
DeviceAMPLIFED MYCOBACTERIUM TUBERCULOSIS DIRECTOR (MTD) TEST
ApplicantGEN-PROBE, INC.
10210 GENETIC CENTER DR.
SAN DIEGO, CA 92121
PMA NumberP940034
Supplement NumberS009
Date Received10/19/1998
Decision Date12/01/1998
Reclassified Date 06/23/2014
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for additional text under Warnings: "Sediments prepared using Alpha-Tec Systems, Inc. NAC-PAC(TM) XPR-plus(TM) A.F.B. Processing Buffer have been shown to interfere with amplification."
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