Nucleic Acid Amplification Test platform (NAAT)

Type of medical device or related product
General vs. specific use (health condition)
Intended population age
Intended population sex
Level of technical knowledge
Capital
Reusable
Requirements
air conditioning / temperature control
electricity (mains)
other
Healthcare unit
EMDN related code(s)
W0205
NUCLEIC ACID TESTING INSTRUMENTS
GMDN related code(s)
61957
Nucleic acid sequence analyser IVD, next-generation sequencing (NGS) (A mains electricity (AC-powered) automated laboratory instrument intended to determine the sequence of nucleotides in a nucleic acid library [pre-constructed from deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] for genetic analysis of a clinical specimen, using a next-generation sequencing (NGS) technique. It consists of a detector (e.g., fluorescent, luminescent or electrochemical) which detects signals from incorporated nucleotides, as well as sample processing, data processing, and/or data display software. It operates with minimal technician input and complete automation of all procedural steps.)