Nucleic acid microarray probe chip IVD

Definition

A collection of oligonucleotide probes intended to be used for the simultaneous hybridization of multiple amplified nucleic acid targets from a clinical specimen, for subsequent genome or transcriptome analyses [e.g., single nucleotide polymorphisms (SNPs) genotyping, gene expression profiling]. It typically consists of multiple sequence-specific probes immobilized on a solid substrate (e.g., glass), in a microarray format, also referred to as a chip. This device does not include amplification reagents, detection enzymes or reagents for fluorescence-based signal detection. This is a single-use device.

GUDID devices

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Last updated

2025-05-22 14:26:00