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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 NameELECSYS HBSAG
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP990012
Supplement NumberS013
Date Received01/31/2012
Decision Date12/20/2012
Product Code
LOM[ Registered Establishments with LOM ]
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 transfer of a portion of the manufacturing operations for the bulk solutions of reagents r1 and r2, as well as bulk solutions of pretreatment reagents to newly constructed manufacturing space.
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