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