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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.
 
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
Supplement NumberS004
Date Received09/04/2020
Decision Date11/16/2020
Decision Approved
Product Code
QST[ Registered Establishments with QST ]
Advisory Committee Microbiology
Supplement TypeReal Time Process
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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