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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 NameANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATORS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameantibody to hepatitis b surface antigen (anti-hbs) assay
ApplicantORTHO-CLINICAL DIAGNOSTICS, INC.
PMA NumberP000014
Supplement NumberS027
Date Received02/14/2014
Decision Date03/10/2014
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of negative samples in the final release qc test, and an addition of the raw material combination test in the manufacture of the conjugate reagent.
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