Product Approval Information
Proper Name: Human Immunodeficiency Virus Type 1 (HIV-1 Nucleic Acid Testing/Synthetic)
Tradename: APTIMA HIV-1 RNA Qualitative Assay
Manufacturer: Gen-Probe, Inc, License #1592
Package Insert (PDF - 2.1 MB) - October, 2006
Date: October 4, 2006
Indication: Qualitative detection of human immunodeficiency virus type 1 (HIV-1) in human plasma. It is intended for use as an aid in diagnosis of HIV-1 infection, including acute or primary infection.
October 4, 2006 Approval Letter
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