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46

Date:2016/9/2 Views:1008

No.

Product Name

Approval Number

(registration number)

Approval Date

1

Human Immunodeficiency virus (HIV)  type 1 and 2 ELISA  diagnostic kit

State Food and Drug Administration (SFDA)

16th June,2000

EU CE Certification

9th October, 2008

2

Human T-lym-photropic virus (HTLV) type 1 and 2 sandwich ELISA diagnostic kit

State Food and Drug Administration (SFDA)

22th January, 2001

3

Anti-hepatitis C virus ELISA diagnostic kit

State Food and Drug Administration (SFDA)

9th March, 2001

EU CE Certification

16th December, 2013

4

Treponema pallidum Antibody ELISA diagnostic kit

State Food and Drug Administration (SFDA)

7th March, 2001

EU CE Certification

3rd February, 2009

5

Treponema pallidum Antibody  colloidal gold diagnostic kit

State Food and Drug Administration (SFDA)

30th January, 2003

6

Human Immunodeficiency virus (HIV)  type 1 and 2  colloidal gold  diagnostic kit

State Food and Drug Administration (SFDA)

29th January, 2003

Human Immunodeficiency virus (HIV)  type 1/2  colloidal gold diagnostic kit

State Food and Drug Administration (SFDA)

5th August, 2003

7

Hepatitis B virus core Antibody (HBcAb)  ELISA diagnostic kit

State Food and Drug Administration (SFDA)

22th August, 2008

8

Hepatitis B virus core IgM Antibody (HBcAb IgM) ELISA diagnostic kit

State Food and Drug Administration (SFDA)

12th November, 2007

9

Hepatitis E virus IgG Antibody ELISA diagnostic kit

State Food and Drug Administration (SFDA)

12th November, 2007

EU CE Certification

3rd February, 2009

10

Human Immunodeficiency virus (HIV) Antibody ELISA diagnostic kit

State Food and Drug Administration (SFDA)

22th April, 2008

11

Hepatitis E virus Antigen ELISA diagnostic kit

State Food and Drug Administration (SFDA)

18th November, 2008

12

Hepatitis E virus IgM Antibody ELISA diagnostic kit

State Food and Drug Administration (SFDA)

24th June, 2004

EU CE Certification

3rd February, 2009

13

Influenza A virus Antigen Dot-ELISA diagnostic kit

State Food and Drug Administration (SFDA)

14th December, 2009

14

Enterovirus type 71 Antibody IgM ELISA diagnostic kit

State Food and Drug Administration (SFDA)

17th May, 2010

15

Hepatitis B virus Nucleic acid related Antigen ELISA diagnostic kit

State Food and Drug Administration (SFDA)

9th June, 2010

16

Mycobacterium tuberculosis Antibody IgG ELISA diagnostic kit

State Food and Drug Administration (SFDA)

9th June, 2010

17

Influenza virus A sous-type H1N1 (2009) HA Antigen ELISA diagnostic kit

State Food and Drug Administration (SFDA)

14th September, 2010

18

Hepatitis B virus core Antibody (HBcAb) DS-ELISA diagnostic kit

State Food and Drug Administration (SFDA)

25th November, 2010

19

Hepatitis B virus Surface Antigen (HBsAg) CLIA diagnostic kit

State Food and Drug Administration (SFDA)

30th January, 2011

20

Oral Mucosal Exudate  type 1 and 2 DOT-ELISA diagnostic kit

State Food and Drug Administration (SFDA)

17th February, 2011

21

Coxsackie virus TypeA16 IgM Antibody ELISA diagnostic kit

State Food and Drug Administration (SFDA)

12th April, 2011

Taiwan Department of Health

6th May, 2011

22

Enterovirus type 71 Antibody IgM colloidal gold diagnostic kit

State Food and Drug Administration (SFDA)

26th September, 2011

23

Recombinant human vaccine of hepatitis E(Escherichia coli)

State Food and Drug Administration (SFDA)

1st December, 2011

24

Human Immunodeficiency virus Antigen/Antibody(HIV)CLIA diagnostic kit

State Food and Drug Administration (SFDA)

29th December, 2011

25

Antibody to Hepatitis C virus RIBA Confirmation Kit

State Food and Drug Administration (SFDA)

5th January, 2012

26

Anti-Avian Influenza type H5N1 mouse Antibody

Fujian Food and Drug Administration

20th April, 2012

27

Mycobacterium tuberculosis related  γ-interferon In vitro release ELISA diagnostic kit

State Food and Drug Administration (SFDA)

25th April, 2012

28

Human Immunodeficiency virus (HIV)  type 1 and 2 RIBA  diagnostic kit

State Food and Drug Administration (SFDA)

16th May, 2012

29

Antibody to Hepatitis C virus DS-ELISA diagnostic kit

State Food and Drug Administration (SFDA)

25th May, 2012

30

Hepatitis B virus Surface Antigen (HBsAg) ELISA diagnostic kit

EU CE Certification

27th May, 2012

31

Hepatitis Delta virus Antibody IgG ELISA diagnostic kit

State Food and Drug Administration (SFDA)

13th July, 2012

32

Hepatitis Delta virus Antibody IgM ELISA diagnostic kit

State Food and Drug Administration (SFDA)

13th July, 2012

33

Hepatitis C virus Antibody colloidal gold diagnostic kit

State Food and Drug Administration (SFDA)

20th July, 2012

34

Treponema pallidum Antibody CLIA diagnostic kit

State Food and Drug Administration (SFDA)

20th July, 2012

35

Hepatitis E virus Antibody IgM colloidal gold diagnostic kit

State Food and Drug Administration (SFDA)

5th July, 2013

36

Coxsackie virus typeA16 Antibody IgM colloidal gold diagnostic kit

State Food and Drug Administration (SFDA)

11th November, 2013

37

Hepatitis B virus PreS1 Antigen ELISA diagnostic kit

State Food and Drug Administration (SFDA)

11th November, 2013

38

Pre-trigger solution

Xiamen Food and Drug Administration

24th January, 2014

39

Concentrated cleaning buffer

Xiamen Food and Drug Administration

24th January, 2014

40

Sample diluent

Xiamen Food and Drug Administration

24th January, 2014

41

Trigger solution

Xiamen Food and Drug Administration

24th January, 2014

42

Influenza B Virus Antigen  immunofiltration diagnostic kit

State Food and Drug Administration (SFDA)

27th January, 2014

43

Human Immunodeficiency virus (HIV)  type 1 and 2 immunofiltration diagnostic kit

State Food and Drug Administration (SFDA)

27th January, 2014

44

Human Influenza A virus type HA Antigen Enzyme chromatography diagnostic kit

State Food and Drug Administration (SFDA)

31th March, 2014

45

Influenza A/B virus type HA Antigen Enzyme chromatography diagnostic kit

State Food and Drug Administration (SFDA)

31th March, 2014

46

Full-automatic chemiluminescence  immunoassay Analyzer

State Food and Drug Administration (SFDA)

19th June, 2014

 

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