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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 NameABBOTT REALTIME HBV ASSAY
Classification Namehepatitis viral b dna detection
ApplicantABBOTT MOLECULAR, INC.
PMA NumberP080026
Supplement NumberS003
Date Received04/02/2012
Decision Date09/26/2012
Product Code
MKT[ Registered Establishments with MKT ]
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change from a manual assembly system to an automated process for kit packaging.
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