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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.
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
PMA NumberP060034
Supplement NumberS002
Date Received09/30/2008
Decision Date02/20/2009
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an amendment to the package insert with the addition of the statement that allows storage of the working conjugate solution at room temperature for 30 hours, up to 10 cycles of 3 hours at room temperature allowed for the device.