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Premarket Approval Information - Devices

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Product: VERSANT HIV-1 RNA 3.0 Assay (bDNA)
Applicant: Bayer Corporation, Berkeley, CA
PMA number: BP000028/0
Indication for Use: for the direct quantitation of human immunodeficiency virus type 1 (HIV-1) RNA in plasma of HIV-1 infected individuals
Approval Date: 9/11/2002

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Letter - (PDF)

Summary - (PDF)

 

Updated July 9, 2003
 
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