Nucleix , Ltd.

Nucleix, Ltd. specializes in in vitro diagnostic (IVD) devices, specifically nucleic acid extraction and methylation analysis kits. Their products include nucleic acid extraction/isolation kits and methylated DNA IVD kits, such as the Bladder EpiCheck line, which combines test kits, extraction kits, and associated software for detecting and monitoring conditions like bladder cancer. These devices rely on nucleic acid techniques (NAT) to analyze DNA samples.

Nucleix, Ltd. is headquartered in the United States. Their devices are designed for use in the U.S. market, where regulatory pathways like the FDA’s 510(k) and Unique Device Identifier (UDI) listings apply. The company’s focus on Class II devices aligns with FDA requirements for moderate-risk medical products.

Nucleix, Ltd.’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance for Class II devices, which require demonstration of substantial equivalence to a predicate device before commercialization. The UDI system also supports post-market surveillance and identification.

Nucleix, Ltd.’s devices fall under FDA Class II classification. This classification applies to moderate-risk medical devices that require special controls to ensure safety and effectiveness beyond general controls. For example, nucleic acid extraction kits and methylated DNA test kits—like those in the Bladder EpiCheck line—must meet performance standards and labeling requirements to mitigate risks associated with nucleic acid analysis.