QUARK BIOSCIENCES TAIWAN, INC. (HSINCHU PLANT)

Quark Biosciences Taiwan, Inc. specializes in thermal cycler nucleic acid amplification analysers designed for in vitro diagnostic (IVD) use in laboratory environments. These devices are engineered to perform nucleic acid amplification testing, which helps detect and analyze genetic material for diagnostic applications. The company’s focus is on Class II devices, which are regulated as moderate-risk medical products.

The company operates under a U.S.-based corporate structure but maintains a manufacturing facility in Hsinchu, Taiwan. This plant produces the thermal cycler nucleic acid amplification analysers, ensuring compliance with regulatory standards while leveraging Taiwan’s expertise in precision medical device manufacturing.

Quark Biosciences Taiwan, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This inclusion is required for Class II medical devices in the U.S., ensuring transparency and traceability of the products under FDA oversight. The UDI system helps track and regulate these diagnostic tools as part of routine compliance.

Quark Biosciences Taiwan, Inc.’s devices fall under Class II classification in the U.S. regulatory framework. Class II devices are considered to pose moderate risks and require special controls beyond general controls to ensure their safety and effectiveness. This classification applies to their thermal cycler nucleic acid amplification analysers, which are subject to additional scrutiny and documentation requirements.