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Product Approval Information - Licensing Action

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Proper name: Hepatitis C Virus Assay
Tradename: COBAS AmpliScreen HCV Test, v2.0
Manufacturer: Roche Molecular Systems, Inc, Pleasanton, CA, License #1636
Indication for Use: Dectecting HCV RNA, in conjunction with licensed tests for detecting antibodies to HCV
Approval Date: 12/3/2002
Type of submission: Biologics license application

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Approval Letter - (Text)

Label - (PDF)

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

 

Updated September 8, 2003
 
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