At Amoy Diagnostics we take the quality of our products very seriously. The laboratory where the kits are designed and tested is ISO-13485 certified. The manufacturing plant where the kits are assembled is also ISO-13485 certified, as well as GMP-compliant. The laboratory and manufacturing plant are inspected annually to maintain this high level quality by the internationally recognized inspection companyTÜV SÜD.

Each batch of products undergoes rigorous QC testing prior to shipping to ensure that it performs exactly to, or above, all required specifications. We validate on the following PCR machines: Roche LightCycler 480 I, Roche LightCycler 480 II; Stratagene MX 3000P/3005P; ABI Step One Plus, ABI 7300/7500/7900; Bio-Rad IQ5, Bio-Rad CFX96.

Our Quality Management System

0ur continual investment in quality ensures that Amoy Diagnostics exceeds the expectations of its customers and key stakeholders.

Drawing from in-depth scientific knowledge, the proven expertise of its team, and  patented core technologies, Amoy Diagnostics is constantly evolving its rapid diagnostic solutions.

Amoy Diagnostics’s leadership team promotes continuous and proactive process improvement,  problem prevention, and resolution through a company-wide quality system in which all team members embrace the governing and regulatory requirements to maintain the highest standards of integrity and excellence.