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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, V2.0
Classification Namecytomegalovirus (cmv) dna quantitative assay
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP110037
Supplement NumberS003
Date Received11/02/2012
Decision Date01/07/2013
Product Code
PAB[ Registered Establishments with PAB ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for two new versions of amplilink software, v3. 3. 6 and v3. 3. 7.
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