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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS
Classification Namehepatitis a test (antibody and igm antibody)
Generic Nametotal antibody to hepatitis a virus
Regulation Number866.3310
ApplicantBAYER HEALTHCARE, DIAGNOSTICS DIVISION
PMA NumberP040017
Date Received04/01/2004
Decision Date03/07/2005
Reclassified Date 02/09/2006
Product Code
LOL[ Registered Establishments with LOL ]
Docket Number 05M-0110
Notice Date 03/21/2005
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 advia centaur hav total assay and quality control materials. Hav total assay indication for use: the advia centaur hav total assay is an in vitro diagnostic immunoassay for the qualitative determination of total antibodies to hepatitis a virus (anti-hav ) in human serum or plasma (potassium edta, lithium or sodium heparinized) using the advia centaur system. This anti-hav assay is indicated as an aid in the diagnosis of previous or ongoing hepatitis a viral infection or in the identification of hav-susceptible individuals for vaccination. Hav total quality control materials indication for use: for monitoring the performance of the hav total assay on advia centaur systems. The performance of the hav total quality control material has not been established with any other anti-hav total assay.
Approval Order Approval Order
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