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Spacegen has received CE certification for six new products

News source: Release time:[2018-07-24]

Xiamen,China-Spacegen announced today that after five of its products have been CE certified in 2016, another six products have received CE certification.The certificate is issued by EU authorities CA (In UK is MHRA), which is applicable in all the countries of EEA (including EU and EFTA). The certification will approve the six products to be marked CE and allowed to be on market in EEA(European Economic Area).The CE marking is the manufacturer's declaration that the product meets the requirements of the applicable EC directives.



Spacegen now has 11 products which have been approved for CE marking including Table 1. More products have been applied for CE certification now.


No.           Product Name             Specification                     Technology
1

Human thyroid carcinoma RET Gene 

Fusions Detection Kit

20Tests/Kit

Multiplex Fluorescence Polymerase 

Chain Reaction(RT-PCR)

2Human MGMT Gene Methylation Detection Kit

24Tests/Kit

Multiplex Fluorescence Polymerase 

Chain Reaction(RT-PCR)

3

Human EGFR Gene T790M Mutation

 Detection Kit 

20Tests/Kit

Digital PCR
4Human Pharmacogenomics SNP Detection Kit 

16 Tests/Kit, 32 Tests /Kit

High-Throughput Sequencing(NGS

5

Human Radiotherapeutic Side Effect-Related

 Gene SNP Detection Kit 

16 Tests/Kit, 32 Tests /Kit

High-Throughput Sequencing (NGS)
6

Cardiotoxicity Prediction of Breast Cancer

 Detection Kit 

16 Tests/Kit, 32 Tests /Kit

High-Throughput Sequencing (NGS)
7

Human Oncology Multi-Gene Mutations

 Detection Kit

16 Tests/Kit, 32 Tests /Kit

High-Throughput Sequencing (NGS)
8Human BRCA 1/2 Gene Mutation Detection Kit

16 Tests/Kit, 32 Tests /Kit

High-Throughput Sequencing (NGS)
9Human EGFR Gene Mutations Detection Kit      10 Tests /Kit

Multiplex Fluorescence Polymerase

 Chain Reaction(RT-PCR)

10Human K-ras Gene Mutations Detection Kit      10 Tests /Kit

Multiplex Fluorescence Polymerase

 Chain Reaction(RT-PCR)

11Human B-raf Gene Mutations Detection Kit      20 Tests /Kit

Multiplex Fluorescence Polymerase

 Chain Reaction(RT-PCR)
























Table 1


The certification is not only a great recognition of international authorities but also a key development of the company. After years of development, Spacegen have developed many cooperators in domestic  as well as international distributors . More and more distributors are interested in ourproducts.