Premarket Approval Information - Devices
Applicant: ABBOTT Molecular, Inc
Product: Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime HIV-1 Calibrator Kit,
Abbott RealTime HIV-1 Control Kit
PMA number: BP060002 / 0
Indication for Use: Quantitation of Human Immunodeficiency Virus type 1 (HIV- 1) on the automated m2000 System in human plasma for use in conjunction with clinical presentation and other laboratory markers
Approval Date: 5/11/2007