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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 NumberS014
Date Received03/18/2014
Decision Date04/04/2014
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 
Addition of a new supplier for a system component used in the manufacture of the cobas ampliprep instrument.
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