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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Device cobas? HIV-1/HIV-2 Qualitative
Classification Namelab-based hiv nat diagnostic and/or supplemental test
Generic Namelab-based hiv nat diagnostic and/or supplemental test
Regulation Number866.3957
Applicant
Roche Molecular Systems, Inc.
4300 hacienda drive
Pleasanton, , CA 94588 -2722
  
PMA NumberBP190360
Date Received06/13/2019
Decision Date08/12/2020
Decision Approved
Product Code
QST[ Registered Establishments with QST ]
Advisory Committee Microbiology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S003 S004 S005 S006 S007 S009 S010 
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