2008 2008

Establishment Time
8.5w8.5w

LandOccupation
230230

Patent Technology
100100

countries& regions

RAPID TEST APPLICATIONS

Rapid Diagnostic Tests Applications

Browse Biotest's complete test menu by category, from drugs of abuse and infectious disease panels to women's health, cardiac and tumour marker assays, with matching readers and analysers for every format.

About us

Leading Rapid Diagnostic Tests Manufacturer Since 2008

Hangzhou Biotest Biotech is a China-based IVD manufacturer supplying fertility, drugs of abuse, infectious disease, tumour marker and cardiac marker rapid tests built on recombinant antigen and colloidal gold platforms.

ABOUT BIOTEST

Leading Rapid Diagnostic Tests Manufacturer Since 2008

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.

Rapid Diagnostic Test Manufacturer & Supplier

China IVD Manufacturer for POCT Rapid Test Kits

Biotest develops and manufactures drugs of abuse, infectious disease, women's health, oncology and cardiac marker rapid tests in an 85,000 m² facility, supplying distributors in 100+ countries.

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BEST SELLING PRODUCTS

Best-Selling Rapid Test Kits

Our most-ordered rapid test cassettes, dip cards and readers for drugs of abuse, infectious disease, HbA1c and G6PD screening, all available with OEM branding and bulk supply.

+Products

CERTIFICATIONS & QUALITY

Certifications & Regulatory Compliance

Biotest has successfully undergone rigorous quality management system audits by regulatory authorities such as NMPA (China FDA), US FDA, ISO 13485, MDSAP, and the health ministries of various countries/regions. We have established a robust QMS, developed comprehensive production standards, technological documentation, manufacturing SOPs and work instructions, and implemented a robust training system.

EC Certificate — HCV Rapid Test (Directive 98/79/EC)

EC Certificate — HBsAg Rapid Test (Directive 98/79/EC)

EC Certificate — HIV 1.2.O Rapid Test (Directive 98/79/EC)

MDSAP Certificate — TÜV SÜD (AU / BR / CA / JP / US)

EC Certificate — Self-Testing IVDs (hCG, LH, hFSH, Bacterial Vaginosis)

Why Choose Biotest
as Your Supplier

From 230 patents to 603 CE-certified products, Biotest combines in-house
reagent development, automated production and responsive after-sales
support to keep your diagnostic supply chain reliable and competitive.

Production advantage

Since its establishment, the company has focused on research in the field of biotechnology and R&D of bio-high-tech products. As of December 2023, the company has 230 patented technologies, including 171 domestic patents (9 invention patents) and 59 overseas patents (7 Invention patents). Obtained 45 NMPA certificates, EU CE certificates covering 603 products, and 3 US FDA 510(k) certificates covering 21 test products. Products are sold to more than 100 countries and regions around the world.

Professional team

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.

After -sales

Biotest products are currently sold in over 100 countries and regions worldwide, serving a population of over 3 billion. We have partners all over the world. We are expanding our distribution network in Asia, Africa, America and Europe. We are looking forward to more and better global partners to join us, and together we can provide the world with more timely, more accurate and more affordable diagnostic solutions.

Exhibitions & Trade Shows

Meet the Biotest team at leading medical and laboratory exhibitions including CMEF, ADLM, MEDLAB and Analytica to review new rapid tests and discuss distribution opportunities.

CONTACT & SUPPORT

Contact Us to Get Your Testing Solution

Get direct answers about Biotest rapid tests and a tailored sourcing solution: browse the common questions below or send your inquiry, and our export team replies within 24 hours with pricing, samples and regulatory documentation.

Are you a manufacturer or a trading company?

Biotest is a manufacturer. Founded in 2008, we operate our own 85,000 m² facility in Hangzhou with in-house reagent development, automated production lines and quality control laboratories.

What certifications do your rapid tests hold?

Our portfolio carries EU CE certification covering 603 products, 45 China NMPA certificates and 3 US FDA 510(k) clearances covering 21 tests, supported by ISO 9001 and ISO 13485 quality systems.

Do you provide OEM and private label service?

Yes. We offer OEM and ODM manufacturing with custom panel configurations, cassette or strip formats, private-label packaging, artwork design and regulatory documentation for your market.

What is the minimum order quantity and lead time?

MOQ depends on the product format and level of customisation. Standard products usually ship within two to four weeks; OEM orders take longer depending on artwork and packaging approval.

Can I request samples before placing a bulk order?

Yes. Evaluation samples are available for qualified distributors and institutional buyers so you can validate performance in your own setting before committing to volume.

Which markets do you export to?

Biotest products are sold in more than 100 countries and regions across Asia, Africa, Europe and the Americas, and we are actively expanding our distributor network worldwide.

Send Your Inquiry

Tell us your test menu, format and target quantity. Our export team replies within 24 hours.

Or contact us directly: info-B@biotests.com.cn· WhatsApp +86 136 3415 8802

COMPANY & INDUSTRY INSIGHTS

Industry Insights

Product launches, regulatory updates and buyer guides from Biotest, written for distributors, laboratories and procurement teams sourcing rapid diagnostic tests.