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  • Two lines. One result you can trust either way.

    TRUSTED IVD PARTNER
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Home » About Bioteke

Company Profile​​​​​​​​​​​​​​

Since 2005, BioTeke has built its business on two complementary product lines under one quality system.
bioteke corporation-factory
bioteke corporation-office
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.
Manufacturing & GMP Excellence
Manufacturing & GMP Excellence
Manufacturing & GMP Excellence
Manufacturing & GMP Excellence

Quality Infrastructure

ISO Certified GMP Manufacturing

Manufacturing Capability

Manufacturing Facilities

 Factory location
 Production area
 Production lines
 Cleanroom environment
Automated production equipment

Quality Management

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

R&D Capability

 Molecular biology R&D
 Assay development
 Rapid test development
 Product validation
 

Production Control

 Raw material inspection
 In-process QC
 Finished product inspection
 Lot-level traceability
 
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Industry Experience(years)
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Factory (m²)
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Employees
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Production Lines
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R&D Engineers
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Annual Production Capacity
antigen production line-bioteke
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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  • Molecular Precision Molecular Precision
  • Rapid Response Rapid Response
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

  • 01 / Extraction Reagents Nucleic Acid & Protein Extraction
    Over 300 kit formats for genomic DNA, total RNA, viral nucleic acid, and protein extraction — engineered for consistent yield and purity across sample types.
  • 02 / Instrumentation Molecular Diagnostic Instruments
    Automated nucleic acid extraction systems, real-time fluorescent PCR instruments, UV-Vis spectrophotometers, and centrifuges built to run BioTeke reagents at rated performance.
     
  • 03 / Rapid Diagnostics Point-of-Care Test Kits
    Antigen and rapid molecular test cassettes covering respiratory panels (including combined SARS-CoV-2/Flu/RSV/ADV/MP/HMPV detection), HPV, STI, and UTI pathogens.
     
  • 04 / R&D In-House Assay Development
    Dedicated molecular biology R&D teams design and validate new extraction chemistries and assay formats ahead of market and regulatory demand.
     
  • 05 / Manufacturing Controlled Production Environment
    Reagent and cassette manufacturing runs under a documented quality management system, with lot-level traceability from raw material to finished kit.
     
  • 06 / Global Support Distributor & OEM Partnerships
    Technical support, registration assistance, and OEM/private-label programs for distributors bringing BioTeke products into new markets.
     
  • 01 / Extraction Reagents Nucleic Acid & Protein Extraction
    Over 300 kit formats for genomic DNA, total RNA, viral nucleic acid, and protein extraction — engineered for consistent yield and purity across sample types.
  • 02 / Instrumentation Molecular Diagnostic Instruments
    Automated nucleic acid extraction systems, real-time fluorescent PCR instruments, UV-Vis spectrophotometers, and centrifuges built to run BioTeke reagents at rated performance.
     
  • 03 / Rapid Diagnostics Point-of-Care Test Kits
    Antigen and rapid molecular test cassettes covering respiratory panels (including combined SARS-CoV-2/Flu/RSV/ADV/MP/HMPV detection), HPV, STI, and UTI pathogens.
     
  • 04 / R&D In-House Assay Development
    Dedicated molecular biology R&D teams design and validate new extraction chemistries and assay formats ahead of market and regulatory demand.
     
  • 05 / Manufacturing Controlled Production Environment
    Reagent and cassette manufacturing runs under a documented quality management system, with lot-level traceability from raw material to finished kit.
     
  • 06 / Global Support Distributor & OEM Partnerships
    Technical support, registration assistance, and OEM/private-label programs for distributors bringing BioTeke products into new markets.
     
distributor coverage map-bioteke

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.

Partner With Us

Manufacturing Capability
  • ISO13485 Certificate BIOTEKE possesses a quality system for the standardized and stable R&D, production, and management of medical devices.
  • EU IVDR Certificate Demonstrating compliance with the stringent regulatory requirements for self-testing IVD devices in the European Union.
  • FDA 510(k) Cleared FDA clearance based on substantial equivalence to a legally marketed device.
  • European Patent Granted Protecting the innovative technology behind the product saliva-based pregnancy test.
  • Chinese Utility Model Patent Granted Protecting the innovative structural design and technical solution of the products for multi-target bidirectional immunochromatography technology.
  • Invention Patent Freeze-Drying Technology for Fluorescent PCR Reagents
  • ISO13485 Certificate BIOTEKE possesses a quality system for the standardized and stable R&D, production, and management of medical devices.
  • EU IVDR Certificate Demonstrating compliance with the stringent regulatory requirements for self-testing IVD devices in the European Union.
  • FDA 510(k) Cleared FDA clearance based on substantial equivalence to a legally marketed device.
  • European Patent Granted Protecting the innovative technology behind the product saliva-based pregnancy test.
  • Chinese Utility Model Patent Granted Protecting the innovative structural design and technical solution of the products for multi-target bidirectional immunochromatography technology.
  • Invention Patent Freeze-Drying Technology for Fluorescent PCR Reagents
Connect with us

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.
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CONTACT US
 zr@bioteke.cn
 +86-13357927939
 +8613357927939
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