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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.
 
DeviceGEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
Generic NameSystem, nucleic acid amplification, mycobacterium tuberculosis complex
Regulation Number866.3372
ApplicantGEN-PROBE, INC.
10210 GENETIC CENTER DR.
SAN DIEGO, CA 92121
PMA NumberP940034
Supplement NumberS001
Date Received02/23/1996
Decision Date04/23/1996
Reclassified Date 06/23/2014
Product Code MWA 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR: 1)A COMPONENT (NALC) IN A LIQUID REAGENT (ENZYME DILUTION BUFFER) IS MOVED TO A LYOPHILIZED REAGENT (ENZYME REAGENT), RESULTING IN A STABILITY SHELF LIFE OF 1 YEAR FOR THE REAGENTS AND 1 YEAR FOR THE KIT; 2) ADD AN ADDITIONAL VENDOR OF REVERSE TRANSCRIPTASE; AND, 3) INSIGNIFICANT CHANGES TO THE PACKAGE INSERT
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