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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Letter (PDF - 461 KB)

Label (PDF - 2.3 MB)

Summary (PDF - 3.5 MB)