2,193 devices · GMDN 52521
Nucleic acid extraction/isolation kits for in vitro diagnostic use are designed to isolate DNA or RNA from clinical samples like blood, swabs, or tissue. These kits prepare genetic material for downstream testing, such as PCR or sequencing, enabling accurate detection of pathogens, genetic disorders, or biomarkers.
These kits are typically regulated as in vitro diagnostics (IVDs) and may require compliance with standards like ISO 13485 or FDA 21 CFR Part 820. They are often sold as single-use consumables, requiring validation for specific applications and platforms to ensure reliability in diagnostic workflows.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.