Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)

This category includes diagnostic test kits designed to detect cytomegalovirus (CMV) genetic material in patient samples using nucleic acid amplification techniques. These kits are used clinically to support the diagnosis and monitoring of CMV infection, particularly in immunocompromised individuals such as transplant recipients or neonates.

Devices in this category are in vitro diagnostic (IVD) medical devices that consist of reagent kits and associated materials for nucleic acid testing. They are intended for use in laboratory settings and are regulated based on their intended use and risk profile, with individual products subject to conformity assessment under applicable IVD regulations.