Premarket Approval Information - Devices
Applicant: Roche Molecular Systems, Inc
Product: COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests
COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L
PMA number: BP050069/0
Indication for Use: Quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acid in human plasma for use in conjunction with clinical presentation and other laboratory markers
Approval Date: 5/11/2007