MGI Tech MGISP-100 Automated Sample Preparation System Receives Certification as Class II Medical Device

MGISP-100

On 3 April, MGI’s automated sample preparation system received a Class II medical device registration certificate, becoming the first one-stop gene sequencing preparation system in China to achieve this certification.

The MGISP-100 automated sample preparation system is an automated workstation developed by MGI. It offers comprehensive functionality, high efficiency, stable operation and strong scalability, making it suitable for small and medium-sized laboratories.

The system features an integrated design that covers the entire experimental workflow. It includes preconfigured modules such as a PCR instrument and temperature control units, along with robust anti-contamination measures, and supports customised development. The system enables rapid library preparation and automated batch processing, eliminating repetitive manual steps. This reduces human error, improves the stability and diagnostic accuracy of NGS library preparation, lowers overall costs, and enhances laboratory efficiency.

The MGISP-100 has broad applications across life sciences research, modern agriculture, tumour screening and pathogen identification. Current applications include non-invasive prenatal screening, tumour therapy guidance, rapid pathogen identification and antimicrobial resistance detection, supported by compatible MGI reagent kits. For research use, the system also supports WGS, WES and RNA sequencing, as well as customised workflow development, and offers established solutions for two major library preparation methods widely used internationally.

As the first automated sample preparation system of its kind in China to receive this certification, the MGISP-100 is expected to play a significant role in advancing small and medium-sized laboratories and improving the overall level of automation across the industry.