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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 READYPACK REAGENTS / CONFIRMATORY ASSAY/ QUALITY CONTROL MATERIAL
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
PMA NumberP030049
Supplement NumberS004
Date Received03/09/2009
Decision Date04/09/2009
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding advia centaur xp instrument to the intended use of the approved devices advia centaur hbsag and advia hbsag confirmatory assay. The devices, as modified, will be marketed under the trade name advia centaur hbsag readypack reagents. Advia centaur hbsag readypack confirmatory assay and advia centaur hbsag quality control material are indicated for: advia centaur hbsag readypack reagents 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 heparin) using the advia centaur and advia centaur xp systems. The assay may be used in conjunction with other serological and clinical information to diagnose individuals with acute or chronic hepatitis b infection. This product is not for use for testing or screening pooled samples containing specimens from more than one individual, or otherwise in blood or plasma screening. Advia centaur hbsag readypack confirmatory assay: 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 and advia centaur xp systems. The assay is intended to be used to confirm the presence of hbsag in samples that are repeatedly reactive using the advia centaur assay. Advia centaur hbsag quality control material: for monitoring the performance of the hbsag and hbsag confirmatory assays on the advia centaur systems when using serum.
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