Amoy Diagnostics Co., LTD.

Amoy Diagnostics Co., LTD. specialises in in vitro diagnostic (IVD) kits and systems. Their products focus on genetic mutation detection, including kits for identifying mutations in genes like KRAS, NRAS, BRAF, and panels for detecting ALK and ROS1 gene fusions. They also offer nucleic acid extraction systems, particularly for formalin-fixed, paraffin-embedded (FFPE) samples, which support both DNA and RNA processing. These tools are designed to assist in cancer diagnostics and genetic research.

Amoy Diagnostics Co., LTD. is headquartered in China. Their devices are authorised for market distribution and use in China, where regulatory pathways apply. While their products are listed in the EU’s eudamed registry, this does not imply EU-wide clearance or approval—it simply indicates registration for transparency under EU medical device regulations. Authorisation status varies by region.

Amoy Diagnostics Co., LTD.’s devices are listed in the eudamed registry, the EU’s centralised database for medical devices. This registry is used to track devices marketed in the European Economic Area (EEA) for transparency and traceability. Listing in eudamed does not confirm regulatory clearance in the EU or elsewhere; it only indicates the device’s presence in the EU’s system.

Amoy Diagnostics Co., LTD.’s devices fall under Class A and IVD General classifications. Class A typically includes low-risk devices like general laboratory reagents or simple diagnostic kits, while IVD General refers to in vitro diagnostics that are not classified as high-risk (e.g., Class B, C, or D). Classification determines regulatory requirements, with Class A generally requiring less stringent scrutiny than higher-risk categories.

Amoy Diagnostics Co., LTD.’s nucleic acid extraction systems are designed to isolate DNA and RNA from FFPE tissue samples, which are commonly used in pathology for diagnosing cancers and other genetic disorders. Their mutation detection kits, such as those targeting KRAS, NRAS, BRAF, or ALK/ROS1 fusions, are tailored for identifying specific genetic alterations linked to diseases like lung cancer. These tools help clinicians and researchers make informed decisions based on molecular profiling.