2001
Shenzhen Kang Sheng Bao Bio-Technology Co., Ltd. is established.
Background
Shenzhen Kangshengbao Biotechnology Co., Ltd. (KSB) specializes in rapid tests and POCT solutions, combining over 20 years of experience, certified quality systems, and comprehensive OEM manufacturing capabilities for global diagnostic partners.
25 Year of Innovation in POCT Diagnostics
2003
The company successfully completes the technology transfer and production of caries saliva detection kits for GC Company from Japan.
2004
KSB obtains the Pharmaceutical GMP Certificate for in vitro diagnostic reagents.
2006
The company relocates to a new workshop in Fuyong, Shenzhen.
2007
KSB obtains the EN ISO 13485:2003 quality management system certification issued by TÜV SÜD.
2009
- KSB completes first-phase technology transfer and production of nine ELISA tests for ED Company from Sweden.
- Influenza A, Influenza B, HP, and NeoPT products receive CE marking.
- The company completes second-phase technology transfer and production of eight ELISA tests for ED Company.
2010
Class B products (PSA and FPSA) receive CE certification issued by Notified Body TÜV SÜD.
2018
KSB moves to a new manufacturing facility in Fuhai, Shenzhen, and passes the audit for address change under the Medical Device Production License.
2019
- KSB obtains EN ISO 13485:2016 quality management system certification issued by TÜV SÜD.
- The company successfully obtains 13 certificates for fluorescence immunoassay reagents and the FIA-T6 reader issued by the Guangdong Medical Products Administration.
2024
- KSB reaches a milestone of more than 60 CE-marked products in its portfolio.
- The company continues to expand its CE-certified in vitro diagnostic product portfolio while strengthening its international presence.
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IVD and POCT Expertise
Shenzhen Kangshengbao Biotechnology Co., Ltd. (KSB) is a high-tech enterprise dedicated to the research, development, manufacturing, and commercialization of in vitro diagnostic (IVD) products. The company specializes in ready-to-use rapid tests and point-of-care testing (POCT) solutions designed for clinical and laboratory applications. KSB places strong emphasis on product quality, manufacturing consistency, and responsive customer support. By combining technical expertise with practical production capabilities, the company provides reliable diagnostic solutions tailored to the needs of global healthcare and distribution partners across a wide range of medical testing fields.
Certified Quality Management
Since its establishment, KSB has continuously focused on building and maintaining a comprehensive quality management system aligned with international regulatory standards. In 2008, the company obtained ISO 13485 certification and has maintained the certification ever since through ongoing system improvement and compliance management. KSB’s quality framework incorporates regulatory requirements from multiple international markets and supports strict control throughout product development and manufacturing processes. This long-term commitment to quality assurance provides a strong foundation for product reliability, manufacturing stability, and dependable support for customers and business partners worldwide.
Immunoassay Technology Expertise
With more than 20 years of industry experience, KSB has established a broad technology platform centered on colloidal gold and fluorescence immunoassay technologies. These core technologies support the development and production of multiple diagnostic product categories, including tumor markers, infectious disease markers, cardiac markers, and hormone testing solutions. The company currently offers more than 60 CE-certified products, demonstrating its ability to meet international market requirements. Approximately 80% of KSB’s products are exported to Europe, reflecting the company’s strong presence in overseas markets and long-standing cooperation with international customers.
Comprehensive OEM Services
Built on GMP-compliant manufacturing facilities and production systems, KSB provides a comprehensive range of OEM and manufacturing services for diagnostic partners worldwide. The company’s capabilities include colloidal gold and fluorescence assay production, cassette assembly, packaging assembly, and customized manufacturing support based on client requirements. KSB is equipped to support both semi-finished and finished product supply, helping customers streamline sourcing and production processes efficiently. Through integrated manufacturing capabilities, quality-controlled production, and flexible cooperation models, KSB supports long-term partnerships across a wide range of diagnostic and healthcare applications.
Let’s advance point-of-care diagnostics together
We develop and manufacture lateral flow immunoassays and POCT solutions for partners across diagnostics, life sciences, and healthcare. From custom assay development to OEM manufacturing, we support the full product lifecycle.