On May 10, 2017, the Guangzhou Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration issued an inspection report after conducting strict inspections on the cleanliness, concentration of planktonic bacteria, and concentration of sedimentary bacteria in our GMP workshop, showing that Each functional area of ​​the GMP production workshop has reached the level of 100,000, and each functional area of ​​the positive control room has reached the level of 10,000.

GMP is a set of mandatory quality management standards applicable to industries such as pharmaceuticals, medical devices, and food. A set of operable operating specifications to ensure the safety and stability of product quality. Our company's main products are clinical in vitro diagnostic reagents, which belong to Class III medical devices. The production of such products must be carried out in clean workshops that meet the GMP quality management system, and the product production workshop must reach the level of 100,000. The workshop has reached the level of 10,000.

Product quality is the foundation of an enterprise's survival. The GMP plant successfully passed the verification, marking an important step for our company in the direction of standardized, scientific, modernized production and management and hardware construction of production capacity. The innovative series of dry molecular in vitro diagnostic reagents that do not require a cold chain have laid a solid foundation for a series of procedures required by laws and regulations such as quality management system assessment, product registration inspection, clinical trial, and registration approval declaration.

SignaIDT Biotechnologies (SZ), Inc. is an innovative bio-tech enterprise, dedicated to the development, production and sales of molecular in vitro diagnostic reagents that do not require cold chains. Adhering to the business philosophy of "exploration, innovation, truth-seeking, and integrity", we strive to become a leader in promoting the development of a new generation of in vitro diagnostic reagents and primary medical care in my country.