Introduction

13.4%

Technical Staff

130+

Patented Technology

30+

Registration Certificate

900+m2

Area of Purification Workshop

Hangzhou Biotest Biotech Co., Ltd. – a National High-tech Enterprise, is a professional manufacturer specializing in medical in vitro diagnostic assays and reagents,instrument research and development, and world-class sales and service. Biotest was established in 2008 with headquarters located in the natural scenic Eco-Industrial Park Yuhang District of Hangzhou city. Our flagship facility consists of an area of 85,000 square meters with registered capital of 106 million RMB.

Hangzhou Biotest Biotech Co., Ltd. supplies major IVD categories: fertility health, drug testing/toxicology, infectious disease identification, tumor marker detection and cardiac marker monitoring. Biotest harnesses the world-leading technologies of bioengineering by using gene recombinant antigens, synthetic antigens, mono-specific antibodies and polyclonal antibodies combined with latex and colloidal metal particles on immuno-chromatographic assay scaffold to accomplish our test development goals.

Biotest’s mission is to “provide customers with accurate, convenient and affordable medical test products.” Our elite employees possess the talent and prowess to drive the accelerated yet sustainable development of our enterprises. Over the years, Biotest has been steadfast in adhering to the principle of fostering healthy lives and is committed to funding the constant innovation required to continue our goal of overall wellness for mankind.

In 2015, Biotest embarked on the new journey of strategic global deployment by acquiring the American company Advin Biotech, Incorporated. This event marked our resolve towards penetrating the highly coveted American market. Advin Biotech is FDA registered and specializes in toxicology products including single drug combination and multiple drug combination detection kits. The company provides the most comprehensive drug detection tests for the American and global drug-testing markets including employee screening, medical diagnostics, judicial compliance and military testing.

Company History

    2008

    Company Founded

    2011

    Settled in the "Hangzhou Science and Technology Incubator" project
    Selected as the third batch of key industrial investment projects in Hangzhou
    The five-in-one drug multi-functional project is included in the city's technological innovation project
    certification is included in Hangzhou's major qualification certification projects

    2013

    Won the title of "Hangzhou High-tech Enterprise"
    2 CE certification projects are included in Hangzhou's major qualification certification projects
    Won the title of "Zhejiang Province Science and Technology SME Enterprise"

    2014

    Biotest R&D Center is listed as Hangzhou R&D Center
    certification projects are included in Hangzhou's major qualification certification projects
    Passed TUV ISO13485 quality system certification

    2015

    Won the title of "National High-tech Enterprise"
    Approved by the Municipal Development and Reform Commission to become a "Key Enterprise in the Health Industry of Zhejiang Province"
    The "YE Plan" project passed the acceptance check of Hangzhou Science and Technology Bureau

    Successfully acquired Advin Biotechnology Co., Ltd.
    Complete the shareholding system transformation
    7 products have been approved by China cFDA

    2016

    Formally enter the Chinese market
    The R&D center was recognized as a provincial-level high-tech enterprise R&D center
    18 products have been approved by China cFDA

    2017

    6 products have been approved by China cFDA
    Passed TUV ISO13485 quality system certification review

    2018

    Passed the national high-tech enterprise certification review
    3 products obtained Zhejiang provincial-level industrial new product (new technology) appraisal (acceptance) certificate
    Passed China's intellectual property management system certification

    2019

    The RightSign brand became "Zhejiang Famous Export Brand"
    4 products obtained Zhejiang provincial-level industrial new product (new technology) appraisal (acceptance) certificate

    2020

    2 products have been approved by China NMPA

    Covid-19 antibody detection products are authorized by U.S. FDA EUA
    Passed TUV ISO13485 quality system certification review

Certificates

R&D

R&D and Technology

Biotest is one of the manufacturers with a relatively complete variety of POCT diagnostic reagents in the world. Relying on strong independent innovation and management capabilities, Biotest has established a rapid immunodiagnosis platform, a POCT application technology platform, a biological core raw material technology platform, an automated production technology platform and other industrial technology platforms. On this basis, it has independently researched and developed a technology platform that includes reproduction Hundreds of products in five major product series, including health testing, drug abuse (drug) testing, infectious disease testing, tumor marker testing, and myocardial marker testing, are widely used in domestic and foreign medical institutions, judicial testing systems, and third parties. Testing institutions, disease prevention and control centers, blood collection stations, private clinics, etc.

The company’s main products are developed based on the preparation and labeling technology of colloidal gold/latex/fluorescent particles, immunochromatography technology, monoclonal antibody technology, etc. Compared with traditional diagnostic methods, they have strong specificity, high sensitivity, it is simple, fast, and cost-effective. Generally does not require special equipment, and suitable for large-scale screening. At the same time, Biotest continues to invest in molecular diagnostic technology platform and animal disease detection service platform related technology reserves, as a strategic technology platform, laying the foundation for continuous business technology innovation in the future.

The company has 134 patented technologies at home and abroad, including 113 domestic patents (including 5 invention patents) and 21 overseas patents (including 1 invention patent); the company also owns 2 domestic software copyrights. Biotest 's products have obtained relevant registration certificates in more than 30 countries and regions including Asia, North America, Europe, South America, and Africa, and the products are sold all over the world.

In 2015, Hangzhou Biotest Biotech Co., Ltd completed the acquisition of Advin Biotechnology Co., Ltd. of the United States. With the technology and talent advantages of the Silicon Valley of the United States, and adhering to the strategy of global research and development, Biotest not only established to provide innovative, timely, high-quality products for the global market, but also offering solution program and development center.

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