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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 ANTI-HBS2 MASTER CURVE MATERIALS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
PMA NumberP100039
Supplement NumberS002
Date Received09/28/2012
Decision Date09/26/2013
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the ad via centaur anti-hbs2 (ahbs2) master curve material. The device, as modified, will be marketed under the trade name ad via centaur antihbs2 (ahbs2) assay, advia centaur anti-hbs2 (ahbs2) quality control material, and advia centaur anti-hbs2 (ahbs2) master curve material and is indicated for: advia centaur anti-hbs2 (ahbs2) assay: the advia centaur anti-hbs2 assay is an in vitro diagnostic immunoassay for the qualitative and quantitative detennination of total antibodies to hepatitis b surface antigen in human adult, adolescent, and pediatric serum or plasma (edta, lithium-heparinized, or sodium-heparinized) and neonatal samples using the advia centaur and advia centaur xp systems. The assay results may be used as an aid in the detennination of susceptibility to hepatitis b virus (hbv) infection in individuals prior to or following hbv vaccination or where vaccination status is unknown. Assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. This assay has not been fda-cleared or approved for the screening of blood or plasma donors. Advia centaur anti-hbs2 (ahbs2) quality control material: for in vitro diagnostic use in monitoring the performance of the anti-hbs2 assay on the advia centaur systems. The performance of the anti-hbs2 quality control material has not been established with any other anti-hbs assays. Advia centaur anti-hbs2 (ahbs2) master curve material: the advia centaur anti-hbs2 (ahbs2) master curve material (mcm) is for in vitro use in the verification of calibration and reportable range of the ad via centaur ahbs2 assay.
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