Turtle Technology's Digital Fully Automated Integrated Device Obtains Medical Device Registration Certificate
News - 24-04-07

Recently, the digital fully automated sample processing system developed by Jiangsu Shengji Gene Technology Co., Ltd., a subsidiary of Turtle Technology, has obtained the NMPA medical device registration certificate.

The acquisition of this registration certificate is expected to significantly promote the wider use of Turtle Technology's digital PCR and the supporting diagnostic reagents from partners in medical institutions. It will also promote the global layout of Turtle Technology's world-leading miniaturized integrated systems for digital molecular diagnostics, such as the SCI DigitalTM Digital PCR and the ISO DigitalTM Digital Isothermal Amplification System, in the fields of life sciences and precision medicine.

The SCI DigitalTM digital PCR integrated device achieves a three-in-one function of droplet preparation, PCR amplification, and reading analysis, while also achieving full process automation from sample addition to chip reading. Moreover, it innovatively integrates the function of Exponential Ultra-Multiplex Digital PCR Detection (a single reaction can easily achieve >15 multiplex quantification), with the fastest manual operation time of only about 1 minute:


The ISO DigitalTM Digital Isothermal Amplification System realizes a four-in-one function of isothermal reagent system mixing, droplet preparation, isothermal amplification, and reading analysis. It is also the first commercially available fully automated digital isothermal amplification system worldwide, compatible with the current mainstream isothermal reagents such as LAMP, ERA, RPA, SAT, and enables digital quantitative detection:


Turtle Technology is committed to the continuous innovation of microfluidic chips and life science instrument system platforms. With an open and sharing spirit, it conducts in-depth cooperation with enterprises in the biotechnology industry and life science researchers, leading molecular diagnostics into the digital era.




About Turtle Technology


Turtle Technology is committed to leading the life sciences and molecular diagnostics into the digital era. Having been approved as the National Demonstration Center for Genetic Testing Technology and obtaining the first Digital PCR Metrological Evaluation Certificate, we have introduced a variety of digital PCR systems. This marks a comprehensive technological innovation across the entire industrial chain, including genetic testing instruments, chip consumables, Ultra-Multiplex technology, and ultra-high specificity polymerase.


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