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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 NameVITROS ANTI-HBC IGM
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameanti-hbc igm assay
ApplicantORTHO-CLINICAL DIAGNOSTICS, INC.
PMA NumberP030026
Supplement NumberS026
Date Received10/17/2012
Decision Date11/13/2012
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 
Modifications to the component parts of the luminometer signal processor board (lspb). The lspb is used on the vitros eci/eciq immunodiagnostic system, the vitros 3600 immunodiagnostic system and the vitros 5600 integrated system.
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