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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 NameADVIA CENTAUR HBSAG & CONFIRMATORY ASSAYS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
PMA NumberP030049
Supplement NumberS002
Date Received07/30/2008
Decision Date09/25/2009
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the transition of the advia centaur hbsag assay and the advia centaur hbsag confirmatory assay to a new platform in the centaur family of instruments, the centaur cp. Advia centaur hbsag readypack reagents on the centaur cp analyzer: the advia centaur hbsag assay is an in vitro diagnostic immunoassay for the qualitative detection of hepatitis b surface antigen (hbsag) in human serum and plasma (potassium edta, lithium or sodium heparinized) using the advia centaur cp system. The assay may be used in conjunction with other serological and clinical information to diagnose individuals with acute or chronic hepatitis b infection. The assay may also be used to screen for hepatitis b infection in pregnant women to identify neonates who are at risk of acquiring hepatitis b during the perinatal period. The advia centaur hbsag confirmatory assay readypack on the centaur cp analyzer: the advia centaur hbsag confirmatory assay is an in vitro diagnostic immunoassay for the qualitative confirmation of the presence of hepatitis b surface antigen (hbsag) in human serum and plasma (potassium edta, lithium or sodium heparin) using the advia centaur cp system. The assay is intended to be used to confirm the presence of hbsag in samples that are repeatedly reactive using the advia centaur hbsag assay. Advia centaur hbsag quality controls on the centaur cp analyzer: for monitoring the performance of the hbsag and hbsag confirmatory assays on the advia centaur systems. The performance of the hbsag quality control material has not been established with any other hbsag or hbsag confirmatory assays.
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