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

This category includes in vitro diagnostic kits designed to detect the genetic material of HIV1, Hepatitis C virus, and Hepatitis B virus in patient samples using nucleic acid testing techniques. These tests help identify active infections by detecting viral DNA or RNA in blood or other specimens.

Devices in this category are typically supplied as complete kits containing all necessary reagents and materials for testing. They are regulated as in vitro diagnostic devices and may require different levels of regulatory approval depending on the specific jurisdiction and intended use.