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Assure Tech.(Hangzhou) Co., Ltd. was established by senior experts of in-vitro diagnostics industry in 2008. As a high-tech biotechnology company, Assure Tech is specialized in research & development, production, sales of diagnostic reagents, POCT and biological materials.

The company currently has R&D and manufacturing base, which contains the advanced level of colloidal gold diagnostic reagents production lines with annual production capacity of hundreds of millions of devices.

Currently, the Assure R&D team has more than 100 staff who have built an extensive cooperation with advanced domestic and foreign research institutions. In domestic, Assure tech includes an advanced level in the rapid diagnostic reagents, rapid molecular diagnostic area, the development and preparation of antibodies, small molecular antigen synthesis, and genetic engineering. What's more, Assure Tech is committed to R&D in the in vitro diagnostic reagents area and related products: colloidal gold rapid detection reagents, quantitative determination of chemiluminescence immunoassay reagent, and bioactive materials. More than 100 products in the 8 series are successfully developed. They contain the following tests:Drug of Abuse Tests,Infectious Disease Tests,Fertility Tests,Tumor Markers Tests,Cardiac Markers Tests,Biochemical Tests,Allergy Tests and Chronic Disease Series.

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  • Serving the world
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Corporate Culture


Provide excellent IVD health care products to meet human health need

Being one of the global leading high-tech biotechnology industries in the area of evergreen

Customer first and perpetual going-concern
Human-oriented and sincerity managing
Down to earth and look up at the stars
Unity and progress, cooperative and pragmatic

Development History

01 / Assure Tech. (Hangzhou) Co., Ltd. was established
01 / Created two own brands, Fastep and Ecotest
02 / Opened the international market with drugs and pregnancy products
01 / Selected as a "Young Eagle Project" enterprise
02 / The company's plant was expanded and moved to Xiyuan 3rd Road
03 / Optimize the product line to develop infectious disease products
01 / Obtained a medical device manufacturer license
02 / Launched a series of myocardial products, including Troponin I and Cardiac Markers 3 in 1 Combo Test.
01 / Passed ISO 13485 system certification
01 / Won the provincial science and technology small and medium-sized enterprises
02 / HCG Rapid Test, LH Rapid Test, FSH Rapid Test passed the FDA I certification in the United States
03 / Troponin I tests (colloidal gold method) obtained medical device registration certificate
04 / Morphine detection kit (colloidal gold method) obtained the medical device registration certificate, the first class III drug registration certificate
01 / Won the National Key Support High-tech Enterprise (Xihu District)
02 / Chlamydia tests and prostate specific antigen tests passed the EU CE list B product certification for the first time
03 / Passed the US FDA on-site system audit
04 / Gastric Helicobacter pylori antigen tests(colloidal gold method) obtained the medical device registration certificate, the first three-category infectious disease registration certificate
01 / Was recognized as a national high-tech enterprise
02 / Became the city's enterprise high-tech research and development center
03 / Several drug tests such as barbiturate passed the US FDA (510K) Class II certification for the first time
04 / Early pregnancy, ovulation, FOB and a series of drug testing reagents passed the Canadian MDL Class II certification for the first time
01 / Was awarded the provincial high-tech enterprise research and development center
02 / "Hemoglobin Analyzer" obtained the medical device registration certificate, the first POCT product registration certificate
03 / Drug test products were shortlisted in the Ministry of Public Security recommended procurement catalog, among which the morphine and methamphetamine among the finalists ranked first in quality in the "Ministry of Public Security Drug Abuse Test Kit Inspection and Appraisal Results"
01 / Sales achieved a breakthrough of 100 million yuan
02 / "Hemoglobin Test Strip (Dry Chemical Method)" obtained medical device registration certificate
01 / It obtained the MDSAP certificate of the first five-country joint single quality system audit in the industry in the country
02 / The number of "drug multipanel and urine cup tests" expanded to 16 and passed the US FDA (510K) Class II certification
03 / "Dry Fluorescence Immunoassay Analyzer" obtained the medical device registration certificate. The first registration certificate of fluorescence platform
01 / Completed the shareholding system restructuring
01 / Submit an application for IPO listing application to the Shanghai Stock Exchange and successfully pass the issuance review meeting
02 / Zhejiang Provincial Research Institute
03 / Covid-19 antibody tests passed U.S. EUA
04 / Drug Multipanel and Urine Cup Tests passed Canadian MDL Class III Certification for the first Time
01 / Assure Tech.(Hangzhou) Co., Ltd. is successfully listed in SSE STAR Market  
02 / shortlisted as a national-level specialty, special new key "Iittle giant" enterprise supported by recommendations
03 / Our company's "Synthetic Cannabis ADBB Detection Reagent (colloidal gold method)", "Ketamine Detection Reagent (colloidal gold method)" and other products were approved by the Institute of the Ministry of Public Security

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