MGI Tech Co., Ltd.'s subsidiary has obtained the medical device registration certificate for its gene sequencing instrument products.
HuaDa Smart Creation (688114.SH) announced that its wholly-owned subsidiary Shenzhen HuaDa Smart Creation Biomedical Electronics Technology Co., Ltd. recently obtained the medical device registration certificate of the People's Republic of China for its genetic sequencer products.
MGI Tech Co., Ltd. (688114.SH) announced that its wholly-owned subsidiary, Shenzhen MGI Tech Co., Ltd. Bio-Electronic Technology Co., Ltd., recently received the medical device registration certificate from the People's Republic of China for its gene sequencer product.
This product utilizes the united probe anchored polymerization sequencing technology and is used clinically for sequencing of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) samples from human body, to detect gene sequences that can be used to assist in diagnosing diseases or disease susceptibility. This instrument is limited for clinical use in conjunction with in vitro diagnostic reagents and software approved by the national drug regulatory authorities, and is not intended for whole genome sequencing or de novo sequencing in humans.
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