HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

This category includes in vitro diagnostic kits designed to detect and measure the genetic material of HIV-1, HIV-2, hepatitis C virus, and hepatitis B virus in patient samples. These tests use nucleic acid amplification techniques to identify viral RNA or DNA, supporting diagnosis, monitoring of infection, and assessment of treatment response in clinical settings.

Devices in this category are supplied as complete reagent kits containing all necessary components for testing and are regulated as in vitro diagnostic medical devices. Their regulatory classification depends on the intended use and jurisdiction, but they are subject to standard IVD regulations governing performance, safety, and quality without implying any specific approval status.