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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 AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests; COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L
Classification Namehuman immunodeficiency virus (hiv) viral load monitoring test
Generic Namehuman immunodeficiency virus (hiv) viral load monitoring test
Regulation Number866.3958
Applicant
Roche Molecular Systems, Inc.
4300 hacienda drive
Pleasanton, , CA 94588 -2722
  
PMA NumberBP050069
Date Received11/10/2005
Decision Date05/11/2007
Decision Approved
Product Code
QUM[ Registered Establishments with QUM ]
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S005 S006 S007 S008 S009 S010 S011 S012 S014 
S015 S016 S017 S018 S019 S020 S021 S024 S032 
S033 S035 S036 S038 S039 S041 S042 S043 S044 
S045 S046 S047 S051 S052 S053 S055 S056 S058 
S059 S060 S061 S062 S063 S064 S065 S066 S068 
S069 S070 S072 S073 S074 S075 S077 S078 S079 
S082 S083 S084 S085 S086 S087 S088 S089 S091 
S092 S093 S094 S095 S096 S097 S098 S099 S100 
S101 S102 S103 S105 S106 S107 S108 S109 S110 
S112 S113 S115 
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