Introduction

13.4%

Technical Staff

130+

Patented Technology

30+

Registration Certificate

900+m2

Area of Purification Workshop

Hangzhou Biotest Biotech Co., Ltd, established in 2008 and headquartered in Hangzhou, China, specializes in the research, development, production, and sales of in vitro diagnostic (IVD) reagents. As a leader in China’s IVD industry, Biotest is renowned for its innovation and comprehensive product range.

 

The company's primary offerings include Point-of-Care Testing (POCT) rapid diagnostic reagents, making it one of the few global manufacturers with an extensive POCT product line. Biotest’s products are categorized into five main areas: drug abuse testing, infectious disease testing, fertility health testing, tumor marker testing, and cardiology marker testing. These products are widely utilized across various medical institutions, judicial testing systems, third-party testing organizations, Centers for Disease Control and Prevention (CDC), and private clinics both domestically and internationally.

 

Biotest’s industry achievements have earned it recognition and awards. The company was named a Hangzhou high-tech enterprise in 2013 and a national high-tech enterprise in 2019. In 2022, the RightSign brand received the honorary title of "Zhejiang Famous Export Brand" from the Zhejiang Provincial Department of Commerce. In 2023, Biotest was recognized as the Enterprise Technology Center and "Cloud Enterprise" in Zhejiang Province's manufacturing industry.

 

Biotest is dedicated to global market expansion. In March 2015, it acquired Advin Biotech in the United States, establishing itself as a leading technological provider of drug testing products in North America and globally. This acquisition allowed Biotest to set up a research and development and production base in the U.S., leveraging American technological strengths to deliver cutting-edge diagnostic products worldwide.

 

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.

    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

    2021

    Biotest became a listed company on the SSE SciTech innovation board (STAR ). Stock Code: 688767

    Obtain COVID-19 Antigen Rapid Test Self-Testing CE Certification

    2022


    ADVIN COVID-19 Antigen Test @Home US FDA EUA authorized


    Obtain COVID-19 Antigen Rapid Test Saliva Self-Testing CE Certification


    2023

    Accredited as a specialized and innovative enterprise


    The first batch of 69 products obtained EU IVDR certification


    Recognized as the Enterprise Technology Center of Zhejiang Province


    Recognized as  "Cloud Enterprises" in the manufacturing industry of Zhejiang Province

    2024

    FluidicNow Active Microfluidic Immunology Platform officially unveiled, creating a new chapter in the industry


     H. pylori test reagent was awarded the EU IVDR certificate.


    The results of the NIH research project participated by Biotest were published in international authoritative journals.


    Innovative COVID-19+Flu A&B+RSV Antigen Combo Rapid Test Sell Sheet were launched globally, filling the gap in the market.


    7 new Class II medical device registration certificates

Certificates

R&D

R&D and Technology

Biotest’s POCT diagnostic reagents leverage advanced technologies such as colloidal gold/latex/fluorescent particle preparation and labeling, immunochromatography, and monoclonal antibody techniques. These innovations ensure high specificity, sensitivity, and simplicity, offering significant advantages over traditional diagnostic methods, including rapid results, low cost, no need for special equipment, and suitability for screening purposes. These features significantly contribute to the advancement of laboratory medicine.

As one of China’s leading manufacturers of POCT in vitro diagnostic reagents, Biotest boasts an excellent R&D team and a high-quality management team with a forward-thinking and innovative mindset. The company is committed to providing advanced, high-quality, and cost-effective diagnostic products and services to meet global medical needs, promoting a technology-based, green, and healthy new life.

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