Development History

1. Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd. was established in 2001.

2. Successfully completed the technical transfer and production of caries saliva detection productsfor GC Company from Japan in 2003.

3.Obtained the "Pharmaceutical GMP Certificate" within the scope of in vitro diagnostic reagent in 2004.

4. Move to the new clean workshop in Fuyong, Shenzhen in 2006.

7.In 2007, successfully received the EN ISO 13485:2003 certificate of quality management system issued by TÜV SÜD.

8.Successfully completed the technical transfer and production of the first stage of 9 enzyme-linked autoimmunity tests (ELISA)          for ED company from Sweden in 2009.

9. Influenza A, Influenza B, HP and NeoPT products successfully received CE mark. Successfully completed the technical transfer and production of second stage of 8 enzyme-linked autoimmunity tests (ELISA) for ED company.

10. List B product (PSA and FPSA) received the CE certificate issued by Notified Body TÜV SÜD.

11. Moved to the new clean workshop in Fuhai,Shenzhen, and passed the audit for address change under the Medical Device Production License in 2018.

12.In 2019, successfully received the EN ISO 13485:2016 certificate of quality management system issued by TÜV SÜD.

13. Successfully received 13 certificates of fluorescence immunoassay reagents and the reader (FIA-T6) issued by Guangdong Medical Products Administration.

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