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Product Approval Information - Licensing Action

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Proper name: Human Immunodeficiency Virus Type 1
Tradename: COBAS AmpliScreen HIV-1 Test, version 1.5
Manufacturer: Roche Molecular Systems, Inc, Pleasanton, CA, License #1636
Revised package insert: Qualitative in vitro test for direct detection of HIV-1 RNA in human plasma from donations of whole blood and blood components for transfusion
Approval Date: 12/20/2002
Type of submission: Biologics license application

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Approval Letter - (Text)

Label - (PDF)

Summary of Basis for Approval - (PDF), (Text)

 

Updated January 27, 2003
 
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