关于我们

Shenzhen Flash Biotechnology Co., Ltd., established in 2023, is located in Longgang District, Shenzhen, a pioneering demonstration zone. With a current site area of 1,300 square meters, it is a high-tech enterprise focused on the research, development, production, and sales of in vitro diagnostic (IVD) products, providing professional services for global IVD companies. The company has obtained ISO13485 quality management system certification . Its products are primarily used in IVD/POCT rapid testing, serving the public in areas such as drug testing, veterinary testing, and human diagnostics. Since its inception, the company has adhered to the operational principles of valuing talent and building credibility through professionalism. By gathering industry elites, it integrates advanced product technologies from home and abroad with customer needs and its own expertise to offer comprehensive solutions. This approach efficiently helps customers improve their product systems and enhance production capabilities, enabling them to maintain competitiveness in the fierce market. Based on providing the best products, services, and credibility, the company offers comprehensive one-stop supporting services to its clients.

发展历程

2023
  • Shenzhen Flash Biotechnology Co., Ltd. is established, officially entering the IVD industry.

  • Completion of the development and construction of the POCT (Point-of-Care Testing) platform, encompassing Colloidal Gold Immunochromatography, Fluorescence Immunochromatography, and Chemiluminescence methodologies.

  • Obtained Class I In Vitro Diagnostic (IVD) Reagent Filing​.

  • Obtained Class II Medical Device Business License​.

  • ​Obtained Class III Medical Device Operating License​.

  • ​Successfully passed the ISO 13485 Quality Management System audit.​

  • 2023-01
  • 2023-03
  • 2023-04
  • 2023-05
  • 2023-07
  • 2023-12

Company Vision​

Dedicated to excellence in products, service, and integrity, we make a brilliant and impactful presence in the IVD industry.

Honors & Qualifications​

获得第一类体外诊断备案
获得第二类体外诊断备案
获得第三类体外诊断备案
获得13485体系认证