Biotest Biotech - Rapid Test & IVD Manufacturer Since 2008
Hangzhou Biotest Biotech Co., Ltd. is a National High-tech Enterprise and a trusted IVD manufacturer delivering rapid diagnostic solutions to over 100 countries.
IVD Rapid Test Manufacturer Since 2008
Biotest's mission is to "provide customers with accurate, convenient and affordable medical test products."
Hangzhou Biotest Biotech Co., Ltd. – a National High-tech Enterprise – is a professional manufacturer specializing in medical in vitro diagnostic (IVD) assays and reagents, instrument research & development, and world-class sales and service.
Established in 2008 and headquartered in the natural scenic Eco-Industrial Park, Yuhang District, Hangzhou, Biotest operates a flagship facility of 85,000 square meters with a registered capital of 106 million RMB.
The company supplies major IVD categories: fertility health, drug testing / toxicology, infectious disease identification, tumor marker detection and cardiac marker monitoring – harnessing world-leading bioengineering technologies built on gene recombinant antigens, synthetic antigens, mono-specific and polyclonal antibodies combined with latex and colloidal metal particles on an immunochromatographic assay scaffold.
Mission, Vision and Values
Clear purpose and principles that guide every product we ship and every partner we serve.
Our Mission
To provide customers with accurate, convenient and affordable medical test products, fostering healthy lives through constant innovation for the overall wellness of mankind.
Our Vision
To be a globally trusted IVD partner – delivering innovative, timely and high-quality diagnostic solutions that make reliable testing accessible in every market we serve.
Our Values
Quality without compromise, customer-first service, and sustainable global growth through R&D and partnership.
Why Choose Our IVD Products
Global R&D Through Advin Biotech (USA)
In 2015 Biotest acquired Advin Biotechnology of the United States, leveraging Silicon Valley's technology and talent. This strategic global deployment established an innovation, solution and development center for the worldwide market.
Deep Toxicology Expertise
Advin Biotech is FDA registered and specializes in toxicology products – single and multi-drug combination detection kits – serving the American and global drug-testing markets: employee screening, medical diagnostics, judicial compliance and military testing.
Production Advantage
As of December 2023, Biotest holds 230 patented technologies, 45 NMPA certificates, EU CE covering 603 products, and 3 US FDA 510(k) certificates – products sold to 100+ countries and regions.
Professional Team & Platforms
One of the world's most complete POCT diagnostic reagent portfolios, built on five industrial technology platforms: rapid immunodiagnosis, POCT application, biological core raw material, and automated production.
R&D Platforms and Product Series
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 hundreds of products in five major product series: reproductive health testing, drug abuse (drug) testing, infectious disease testing, tumor marker testing, and myocardial marker testing – widely used in domestic and foreign medical institutions, judicial testing systems, third-party testing institutions, disease prevention and control centers, blood collection stations and private clinics.
- Rapid Immunodiagnosis PlatformCore immunochromatography for equipment-free rapid screening.
- POCT Application Technology PlatformField-ready diagnostic applications across care settings.
- Biological Core Raw Material PlatformGene recombinant & synthetic antigens for supply stability.
- Automated Production Technology PlatformScalable, consistent high-volume manufacturing.
- Molecular & Animal-Disease PlatformsStrategic technology reserves for future innovation.
Certifications and Quality System
Biotest has successfully undergone rigorous quality management system audits by NMPA (China FDA), US FDA, ISO 13485, MDSAP, and health ministries of various countries/regions. We have established a robust QMS, comprehensive production standards, technological documentation, manufacturing SOPs, work instructions, and a robust training system.
Quality System Certificate
NMPA / CE Certificate
ISO 13485 Certificate
FDA 510(k) Certificate
MDSAP Certificate
Export & Compliance Certificate
IVD Products in 100+ Countries
Biotest products are sold to more than 100 countries and regions, serving a population of over 3 billion. Our distribution network keeps expanding across Asia, Africa, the Americas and Europe.
Asia
Expanding distribution & local partnershipsAfrica
Growing distributor networkAmericas
US subsidiary Advin Biotech (Silicon Valley)Europe
CE-certified product coverageCompany History 2008–2023
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 & development, and world-class sales and service.
Company Founded
Hangzhou Biotest Biotech Co., Ltd. was established in Yuhang District, Hangzhou.
Incubator & Key Project
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 was included in the city's technological innovation project, with certification included in Hangzhou's major qualification certification projects.
High-Tech & SME Recognition
Won the title of "Hangzhou High-tech Enterprise"; 2 CE certification projects were included in Hangzhou's major qualification certification projects. Also won the title of "Zhejiang Province Science and Technology SME Enterprise."
R&D Center & ISO 13485
Biotest R&D Center was listed as a Hangzhou R&D Center; certification projects were included in Hangzhou's major qualification certification projects. Passed TÜV ISO 13485 quality system certification.
National High-Tech & US Acquisition
Won the title of "National High-tech Enterprise" and was approved by the Municipal Development and Reform Commission as 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 were approved by China cFDA.
Entering the Chinese Market
Formally entered the Chinese market. The R&D center was recognized as a provincial-level high-tech enterprise R&D center; 18 products were approved by China cFDA.
cFDA Approvals & ISO Review
6 products were approved by China cFDA. Passed TÜV ISO 13485 quality system certification review.
Re-certification & IP Management
Passed the national high-tech enterprise certification review. 3 products obtained Zhejiang provincial-level industrial new product (new technology) appraisal certificate. Passed China's intellectual property management system certification.
RightSign Export Brand
The RightSign brand became "Zhejiang Famous Export Brand." 4 products obtained Zhejiang provincial-level industrial new product (new technology) appraisal certificate.
NMPA & COVID-19 Response
2 products were approved by China NMPA. COVID-19 antibody detection products were authorized by U.S. FDA EUA. Passed TÜV ISO 13485 quality system certification review.
Listed on STAR Market
Biotest became a listed company on the SSE Sci-Tech Innovation Board (STAR Market). Stock Code: 688767. Obtained COVID-19 Antigen Rapid Test Self-Testing CE Certification.
ADVIN COVID-19 Antigen Tests
ADVIN COVID-19 Antigen Test @Home obtained U.S. FDA EUA authorization. Obtained COVID-19 Antigen Rapid Test Saliva Self-Testing CE Certification.
IVDR & Enterprise Technology Center
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 and as a "Cloud Enterprise" in the manufacturing industry of Zhejiang Province.
In-House IVD Manufacturing
Biotest's mission is to "provide customers with accurate, convenient and affordable medical test products."
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 & development, and world-class sales and service.
Established in 2008 with headquarters in the natural scenic Eco-Industrial Park, Yuhang District, Hangzhou, the flagship facility spans 85,000 square meters with registered capital of 106 million RMB, supplying fertility health, drug testing / toxicology, infectious disease, tumor marker and cardiac marker detection.
- 85,000 m² FacilityEco-Industrial Park, Yuhang, Hangzhou.
- Automated Production LinesConsistent, large-scale output for global demand.
- Robust QMSNMPA / FDA / ISO 13485 / MDSAP audited.
- Self-Developed Raw MaterialsAntigens & antibodies for supply security.
- Global Deployment2015 acquisition of Advin Biotech (USA) for the American & global drug-testing markets: employee screening, medical diagnostics, judicial compliance and military testing.
Sustainability and Responsibility
Affordable Health
Committed to accurate, convenient and affordable diagnostics that broaden access to quality testing worldwide.
Quality & Compliance
A robust QMS, transparent documentation and continuous training keep every batch safe and reliable.
Global Partnership
We grow with distributors and healthcare partners across Asia, Africa, the Americas and Europe.
Frequently Asked Questions
Biotest develops and manufactures in vitro diagnostic (IVD) rapid tests across five major product series: reproductive health, drugs of abuse / toxicology, infectious disease, tumor markers, and cardiac / myocardial markers. Products are built on colloidal gold, latex and fluorescent particle immunochromatography platforms.
Yes. Biotest holds 45 NMPA certificates, EU CE certification covering 603 products, 3 US FDA 510(k) certificates covering 21 test products, ISO 13485 (TÜV) and MDSAP quality system certifications. The company is a National High-tech Enterprise and listed on the SSE STAR Market (stock code 688767).
Yes. Through its US subsidiary Advin Biotech and a global R&D strategy, Biotest offers OEM/ODM services, private-label programs and customized diagnostic solutions for distributors, healthcare providers and institutional buyers worldwide.
Biotest products are sold to more than 100 countries and regions, serving a population of over 3 billion. The distribution network is expanding across Asia, Africa, the Americas and Europe, and the company is actively recruiting new global partners.
Yes. Sample kits are available for qualified distributors and bulk buyers. Please contact our sales team with your target markets and product list to arrange samples and a quotation.
We welcome distributors, wholesalers and healthcare procurement partners. Reach out via the contact details below with your company profile and territory, and our partnership team will follow up within two business days.
Contact Biotest Biotech
Request a quote, product samples or distribution with Biotest Biotech.
Address: 27 Tuyi Road, Cangqian Street, Yuhang District, Hangzhou, Zhejiang, China
Hangzhou Biotest Biotech Co., Ltd. · SSE STAR Market 688767