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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 ANTI-HBS IMMUNOASSAY TEST SYSTEM
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameimmunoassay for antibody t hepatitis b surface antigen; anti-hbs control reagents
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP010054
Supplement NumberS005
Date Received07/11/2006
Decision Date07/28/2006
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in the quality control (qc) testing procedure of raw materials for calibrators and controls.
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