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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC ASSAY
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantORTHO-CLINICAL DIAGNOSTICS
100 INDIGO CREEK DR.
ROCHESTER, NY 14626-5101
PMA NumberP030024
Supplement NumberS017
Date Received10/05/2011
Decision Date11/10/2011
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE CHANGE IN ON-INSTRUMENT STORAGE OF PATIENT SAMPLES FROM 2 HOURS TO 3 HOURS.
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