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DropDx Two-Unit dPCR Systems (CE-IVDR)

China

A clinically validated digital PCR system designed for accurate molecular diagnostics in clinical laboratories with regulatory compliance. The system harnesses advanced microfluidics to generate approximately 20,000 nanoliter droplets per sample, with each droplet containing zero or one target molec...

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Suzhou Rainsure Scientific Co., Ltd.

China

Suzhou Rainsure Scientific is an innovative biotech company specializing in molecular diagnostics platforms using microfluidics, advanced optical systems, and software technology. Founded by PhDs from Ivy League and top international universities with extensive industry experience, the company has secured nearly 100 million yuan from investors including ZhenFund and Volcano Stone Capital. Their digital PCR systems (DropDx-2044, DropX-2000) are the only ones to achieve NMPA, FDA-EUA, and CE-IVD certifications.

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DropDx Two-Unit CE-IVD dPCR System

Rainsure Scientific Co. Ltd. · China

A two-unit CE-IVD marked digital PCR system for molecular diagnostics. This system is certified for in vitro diagnostic use and provides digital PCR capabilities for quantifying DNA and RNA.

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sSPRT™ 4T/8T/12T Sample to Answer Molecular Test System

FlashDx Inc. · United States

sSPRT™ 4T/8T/12T Sample to Answer Molecular Test System Powered by FlashDx®’s proprietary semi-Solid Phase Real-Time PCR technology, the IVDR-certified sSPRT™ 4T/8T/12T Sample-to-Answer Molecular Test System delivers a highly multiplexed, true sample-to-answer solution with the simplest workflow on the market. Designed to meet the EU’s stringent In Vitro Diagnostic Regulation standards, this system ensures compliance without compromising speed or flexibility. Its expandable multi-slot instruments provide full random access to diverse disease panels and sample types—anytime, anywhere—empowering labs to scale testing confidently while adhering to global quality and safety benchmarks.

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FlashDx Molecular Testing System

FlashDx Shenzhen Inc. · China

A fully automated sample-to-answer system for multiplexed molecular syndromic testing powered by proprietary SPRT™ (semi-Solid Phase Real-Time PCR) technology. The system features an expandable multi-slot instrument configuration that enables random access to various diseases and sample types with approximately 1 minute of hands-on time and no additional sample preparation steps. Users can test up to 50 targets from a single sample in a fully enclosed cartridge that minimizes contamination risks, with results provided within one hour.

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