Vaccines, Blood & Biologics
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Roche Amplicor HIV-1 Monitor Test
Product: Roche Amplicor HIV-1 Monitor Test
Applicant: Roche Molecular Systems, Inc., Branchburg, NJ
PMA number: BP950005, Supplement 4
Indication for Use: With Ultrasensitive Processing, an in vitro nucleic acid amplification test for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma; intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients
Approval Date: 3/2/99
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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