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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 NameCOBAS AMPLIPREP/COBAS TAQMAN CMV TEST
Classification Namecytomegalovirus (cmv) dna quantitative assay
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP110037
Supplement NumberS002
Date Received08/17/2012
Decision Date09/14/2012
Product Code
PAB[ Registered Establishments with PAB ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to adjust the environmental testing performed at the rms branchburg facility.
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