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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantABBOT LABORATORIES
PMA NumberP110029
Date Received07/26/2011
Decision Date04/12/2012
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 12M-0372
Notice Date 04/17/2012
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the architect hbsag qualitative, architect hbsag qualitative confirmatory, architect hbsag qualitative confirmatory manual diluent, architect hbsag qualitative calibrators, and architect hbsag qualitative controls. This device is indicated for: architect hbsag qualitative - the architect hbsag qualitative assay is a chemiluminescent microparticle immunoassay (cmia) for the qualitative detection of hepatitis b surface antigen (hbsag) in human adult and pediatric serum and plasma and neonate serum. The assay may also be used to screen for hbv infection in pregnant women to identify neonates who are at risk for acquiring hepatitis b during the perinatal period. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with the hepatitis b virus (hbv) (state of infection or associated disease not determined) in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis b infection. Not intended for use in screening blood, plasma, or tissue donors. Architect hbsag qualitative confirmatory - the architect hbsag qualitative confirmatory assay is a chemiluminescent microparticle immunoassay (cmia) for the qualitative confirmation of the presence of hepatitis b surface antigen (hbsag) in human adult and pediatric serum and plasma and neonate serum by means of specific antibody neutralization. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with the hepatitis b virus (hbv) (state of infection or associated disease not determined) in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis b infection. Not intended for use in screening blood, plasma, or tissue donors. (for additional information, please refer to approval order).
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 
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