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Premarket Approval Information - Devices

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Product: Roche Amplicor HIV-1 Monitor Test
Applicant: Roche Molecular Systems, Inc., Branchburg, NJ
PMA number: BP950005, Supplement 3
Indication for Use: An aid in the management of patients on anti-viral therapy for HIV disease
Approval Date: 3/2/99

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Letter - (PDF), (Text)

Summary - (PDF)

 

Updated March 1, 2001
 
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