普迈德多项产品荣获CE新法规IVDR认证证书

普迈德(北京)科技有限公司自主研发的多项产品荣获由德国卫生部(German Institute of Medical Documentation and Info)签发的欧盟IVDR CE认证证书,产品包括血栓弹力图仪、荧光免疫层析分析仪、胶体金免疫层析分析仪及核酸提取试剂等,强有力的证明了普迈德产品获得了高度认可。






同时,已有34个项目获得了IVDD的CE认证,产品如下

1

Platelet Mapping AA Kit

2

Platelet Mapping ADP Kit

3

Platelet Mapping ADP & AA Kit

4

Thrombelastograph Heparinase Cup Kit

5

Thrombelastograph General Cup Kit

6

Rapid Thrombelastograph Kit

7

Adenovirus IgM Antibody Rapid Test

8

Coxsackievirus IgM Antibody Rapid Test

9

Respiratory Syncytial Virus IgM Antibody Rapid Test

10

Influenza A Virus IgM Antibody, Influenza B Virus IgM Antibody and Parainfluenza Virus IgM Antibody Combined Rapid Test

11

Influenza A virus and Influenza B Virus Antigen CombinedRapid Test

12

Mycoplasma Pneumoniae IgG antibody and IgM Antibody Rapid Test

13

B-type natriuretic Rapid Test

14

C Reactive Protein (hs-CRP+CRP) Rapid Test

15

cTnI Rapid Test

16

D-Dimer Rapid Test

17

Ferritin Rapid Test

18

Gastrin-17 Rapid Test

19

β-hCG Rapid Test

20

Helicobacter Pylori IgG Antibody Rapid Test

21

NT-proBNP Rapid Test

22

Procalcitonin Rapid Test

23

Pepsinogen I, Pepsinogen II Rapid Test

24

Serum Amyloid A Protein Rapid Test

25

Serum Amyloid A Protein/C Reactive Protein (hs-CRP+CRP)   Rapid Test

26

cTnI/Myo/CK-MB Rapid Test

27

ST2/NT-proBNP Rapid Test

28

ST2 Rapid Test

29

25-OH Vitamin D Rapid Test

30

COVID-19 Antigen Rapid Detection Kit (Colloidal Gold)

31

COVID-19 Neutralizing Antibody Rapid Detection Kit (Colloidal Gold)

32

COVID-19 IgM/IgG Antibody Rapid Detection Kit (Colloidal Gold)

33

Influenza A+B and COVID-19 Antigen Combo Rapid Detection Kit (Colloidal Gold)

34

COVID-19 and COVID-19 Mutant Strain (B.1.1.7 Strain) Antigen Rapid Detection Kit (Colloidal Gold)


普迈德(北京)科技有限公司自主研发的产品正在逐步扩大国外市场的布局,更多认证,持续更新,敬请期待!


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