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<span style="font-family:Space Grotesk;">ISO 13485</span> <link href="https://fonts.googleapis.com/css?family=Space Grotesk" rel="stylesheet" type="text/css">
<span style="font-family:Space Grotesk;">100+</span> <link href="https://fonts.googleapis.com/css?family=Space Grotesk" rel="stylesheet" type="text/css">
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Specialized in Product
Home » About Bioteke
Company Profile​​​​​​​​​​​​​​
Since 2005, BioTeke has built its business on two complementary product lines under one quality system.
laboratory-grade molecular reagents for precision, and point-of-care rapid tests for speed — serving laboratories and distributors in more than 100 countries.

Manufacturing & GMP Excellence

BioTeke Corporation is a China-based high-tech IVD manufacturer founded in 2005, specializing in molecular diagnostics, rapid testing solutions, and laboratory technologies.  With ISO 13485-certified manufacturing, patented technologies, and global market experience, BioTeke provides reliable diagnostic solutions to healthcare partners and distributors worldwide.

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Quality Infrastructure

ISO Certified GMP Manufacturing

Manufacturing Capability

Manufacturing Facilities

 Factory location
 Production area
 Production lines
 Cleanroom environment
Automated production equipment

Quality Management

 FISO 13485
 ISO 9001
 CE-related compliance
 Product traceability
Lot control

R&D Capability

 Molecular biology R&D
 Assay development
 
 Product validation
 

Production Control

 Raw material inspection
 In-process QC
 Finished product inspection
 Lot-level traceability
 
21
Industry Experience(years)
50,000+
Factory (m²)
600+
Employees
58
Production Lines
30+
R&D Engineers
600M
Annual Production Capacity
BioTeke Corporation is a Chinese high-tech enterprise specializing in in vitro diagnostics (IVD), headquartered in Beijing with manufacturing operations based in Wuxi, Jiangsu. For two decades, our engineers and molecular biologists have focused on a single mandate: shortening the distance between a biological sample and a clinically reliable answer.
That work now spans more than 300 diagnostic kit SKUs, a line of proprietary lab instruments, and a growing rapid-test cassette range — all manufactured in Wuxi under one ISO 13485-certified quality system, and exported to distributors and laboratories in over 100 countries.
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Milestone

2005

Founded in Beijing
BioTeke is established with a focus on molecular biology, beginning R&D on nucleic acid rapid diagnostic solutions.

 

2017S

Manufacturing scale-up in Wuxi
Production capacity expands with a dedicated manufacturing site in Wuxi, Jiangsu, adding automated extraction systems and PCR instrumentation to the product line.

2020S

Rapid diagnostics & global certification
BioTeke expands into point-of-care antigen and molecular rapid tests, securing ISO 13485, CE, and FDA registrations and extending distribution past 100 countries.

Today

A full-line IVD partner
BioTeke supplies laboratories and distributors with a matched portfolio of extraction reagents, molecular PCR kits & instruments, and rapid test kits, backed by an in-house quality system.

Process Flow

<span style="color:#222222;"><strong>01 / Extraction Reagents</strong></span><br> <span style="font-size:15px;">Nucleic Acid &amp; Protein Extraction</span>
<span style="color:#222222;"><strong>02 /&nbsp;Instrumentation</strong></span><br> <span style="font-size:15px;">Molecular Diagnostic Instruments</span>
<span style="color:#222222;"><strong>03 / Rapid Diagnostics</strong></span><br> <span style="font-size:15px;">Point-of-Care Test Kits</span>
<span style="color:#222222;"><strong>04 / R&amp;D</strong></span><br> <span style="font-size:15px;">In-House Assay Development</span>
<span style="color:#222222;"><strong>05 / Manufacturing</strong></span><br> <span style="font-size:15px;">Controlled Production Environment</span>
<span style="color:#222222;"><strong>06 / Global Support</strong></span><br> <span style="font-size:15px;">Distributor &amp; OEM Partnerships</span>

Our Partners

BioTeke products move through an established distributor network spanning Asia, the Middle East, Europe, Afica and the Americas, supported by BioTeke USA for regional distribution in the United States. BioTeke also engages directly in cross-border healthcare initiatives, including regional biopharmaceutical cooperation forums that connect Chinese IVD manufacturers with emerging markets.
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Manufacturing Capability
<div style="text-align: center;"><span style="font-size:20px;"><strong>ISO13485 Certificate</strong></span><br> <span style="font-size:15px;">BIOTEKE possesses a quality system for the standardized and stable R&amp;D, production, and management of medical devices.</span></div>
<div style="text-align: center;"><span style="font-size:20px;"><strong>EU IVDR Certificate</strong></span><br> <span style="font-size:15px;">Demonstrating compliance with the stringent regulatory requirements for self-testing IVD devices in the European Union.</span></div>
<div style="text-align: center;"><strong><span style="font-size:20px;">FDA 510(k) Cleared</span></strong><br> <span style="font-size:15px;">FDA clearance based on substantial equivalence to a legally marketed device.</span></div>
<div style="text-align: center;"><strong><span style="font-size:20px;">European Patent Granted</span></strong><br> <span style="font-size:15px;">Protecting the innovative technology behind the product saliva-based pregnancy test.</span></div>
<div style="text-align: center;"><strong><span style="font-size:20px;">Chinese Utility Model Patent Granted</span></strong><br> <span style="font-size:15px;">Protecting the innovative structural design and technical solution of the products for multi-target bidirectional immunochromatography technology.</span></div>
<div style="text-align: center;"><span style="font-size:20px;"><strong>Invention Patent</strong></span><br> <span style="font-size:15px;">Freeze-Drying Technology for Fluorescent PCR Reagents</span></div>
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Ready to evaluate BioTeke To Be Your Partner?

Address

No.90, Huiming Road, Huishan, Wuxi City, Jiangsu 214000, China

Send Email

Internation Marketing

zr@bioteke.cn


Whatsapp

BioTeke Sales Team

+86 133 5792 7939

Request Partnership
www.bioteke.cn
zr@bioteke.cn
+86-133-5792-7939
ABOUT US
Since 2005, BioTeke has built its business on two complementary product lines under one quality system. laboratory-grade molecular reagents for precision, and point-of-care rapid tests for speed - serving laboratories and distributors in more than 100 countries.
CONTACT US
  zr@bioteke.cn
 +86-13357927939
 +8613357927939
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