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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 NameABBOTT ARCHITECT CORE ASSAY
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantABBOTT LABORATORIES
PMA NumberP080023
Supplement NumberS001
Date Received06/19/2009
Decision Date12/10/2009
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for migration of the architect® core¿ assay to a new architect® i system family member, the architect® i 1000sr. The architect core reagent kit device is indicated for: the architect core assay is a chemiluminescent microparticle immunoassay (cmia) for the qualitative detection of igg and igm antibodies to hepatitis b core antigen (anti-hbc) in human adult and pediatric serum and plasma (dipotassium edta, lithium heparin, sodium heparin) and neonatal serum. It is intended as an aid in the diagnosis of acute, chronic, or resolved hepatitis b virus (hbv) infection in conjunction with other laboratory results and clinical information.
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