Premarket Approval Information - Devices
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
Letter -
(PDF),
(Text)
Summary - (PDF)
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