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康生保生物- 發(fā)展歷程

1. 2001年深圳康生保生物技術(shù)有限公司成立

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

2. 2003年成功完成日本GC公司齲齒唾液檢測(cè)產(chǎn)品的技術(shù)轉(zhuǎn)接和生產(chǎn)

Successfully completed the technical transfer and production of caries saliva detection products

for GC Company from Japan in 2003.

3. 2004年獲得體外診斷試劑認(rèn)證范圍的《藥品GMP證書》

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

4. 2006年搬遷至深圳福永新潔凈廠房

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

5. 2007年首次通過德國認(rèn)證機(jī)構(gòu)TüV SüD的EN ISO 13485:2003的質(zhì)量體系認(rèn)證。

In 2007, successfully received the EN ISO 13485:2003 certificate of quality management system issued by TüV SüD.

6. 2009年成功完成第一階段瑞典ED公司9個(gè)酶聯(lián)自身免疫產(chǎn)品的技術(shù)轉(zhuǎn)接和生產(chǎn)。

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.

7. 2010年，流感A、流感B、HP、NeoPT 4個(gè)產(chǎn)品CE注冊(cè)成功。成功完成第二階段瑞典ED公司、伯樂公司8個(gè)酶聯(lián)自身免疫產(chǎn)品的技術(shù)轉(zhuǎn)接和生產(chǎn)。

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.

8. 2012年，PSA和FPSA 產(chǎn)品（list B）獲得公告機(jī)構(gòu)TüV SüD頒發(fā)的產(chǎn)品CE認(rèn)證證書。

List B product (PSA and FPSA) received the CE certificate issued by Notified Body TüV SüD.

9. 2018年從深圳福永廠房搬遷至深圳福海新潔凈廠房，并通過《醫(yī)療器械生產(chǎn)許可證》的地址變更審核。

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

10. 2019年成功獲得EN ISO 13485：2016新法規(guī)質(zhì)量體系認(rèn)證證書。

In 2019, successfully received the EN ISO 13485:2016 certificate of quality management system issued by TüV SüD.

11. 2023年獲得12個(gè)熒光免疫層析法試劑產(chǎn)品及1個(gè)配套檢測(cè)儀器熒光免疫層析分析儀（FIA-T6）的注冊(cè)證書。

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