Applicant: Abbott Molecular, Inc.
Product: Alinity m HIV-1
PMA number: BP200455
Indication for Use:
- The Alinity m HIV-1 assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantification of Human Immunodeficiency Virus type 1 (HIV-1) RNA on the automated Alinity m System in human plasma from HIV-1 infected individuals. The Alinity m HIV-1 assay is intended for use in the clinical management of HIV-1 infected individuals in conjunction with clinical presentation and other laboratory markers.
- The Alinity m HIV-1 assay may be used to monitor disease prognosis by measuring the baseline plasma HIV-1 RNA level and to assess response to antiretroviral treatment by measuring changes in plasma HIV-1 RNA levels.
- The results from the Alinity m HIV-1 assay must be interpreted within the context of all relevant clinical and laboratory findings.
- This assay is not intended for use in screening blood, blood products, tissue or organ donors for HIV.
- The assay is not intended as aid in diagnosis or to confirm HIV-1 infection.