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WHY CHOOSE BIOTEKE

Built for Partners Who Need More Than a Manufacturer



  • Full-Pipeline OEM Capability
    From raw antibody formulation through final packaged kits - we own and control every stage of production in-house, eliminating subcontractor risk.
  • Global Regulatory Expertise
    Our regulatory team prepares CE-IVD technical files, FDA 510(k) dossiers, ANVISA registration packages, and country-specific submissions on your behalf.
  • Precision 
    Customization
    Sensitivity thresholds, sample matrix formats, cut-off adjustments, package language, and insert design are all configurable to your market's specific requirements.
  • Long-Term Partnership Model
    A dedicated key account manager, quarterly business reviews, and proactive lifecycle management ensure our relationship scales as your business grows.
PARTNERSHIP MODELS
Four Paths to Bringing Your Diagnostic Brands to Market
  • OEM Private Label
    Validated BioTeke products re-branded and packaged under your label. The fastest path to market with minimal development risk.

     Regulatory-cleared base products
     Custom carton, pouch, and IFU design
     CE marking transfer support
     Low MOQ per SKU
    Fastest time to market
  • Custom Formulation
    Adjust sensitivity thresholds, sample types, or target analytes to meet region-specific requirements or proprietary reader system integrations.

     Cut-off optimization per market
     Sample type(saliva, urine, blood, etc.)
     Lyophilization and liquid reagent formats
     Reader-compatible strip design​​​​​​​
    Tailored performance
  • Co-Development
    Joint IP development programs for novel biomarkers or new diagnostic platforms. For partners with clinical insight seeking a manufacturing and R&D counterpart.

     Milestone-based project timelines
     Shared or licensed IP arrangements
     Joint regulatory strategy
    ​​​​​​​ Clinical validation design support​​​​​​​
    IP-sharing available
  • Distribution Partnership
    Become an authorized regional distributor of BioTeke's branded or OEM product range. Territory rights with defined commercial support commitments.

     Territory exclusivity options
     Co-marketing and training support
     Forecasting and demand planning tools
    ​​​​​​​ Dedicated account manager​​​​​​​
    Territory exclusivity
OEM PRODUCT PORTFOLIO
Multiple SKUs Across Diagnostic Categories

  • Rapid Diagnostic  Test 
    Kits
    Respiratory Kit(5-in-1, 6-in-1, 8-in-1, 10-in-1 etc), Saliva Pregnancy Test, DOA Rapid Test.
  • Molecular Diagnostics & 
    PCR Kits
    HPV Genotyping, STI Screening, UTI Screening, Respiratory Pathogen Panel. ​​​​​​​
  • Nucleic Acid Extraction & Instruments
    Automated Extractor, Extraction Reagents, Sample Collection Swab Kits.​​​​​​​
Custom Packaging & Box Design​​​​​​​
Request OEM Catalog
Private Label Cassette & Strip​​​​​​​
Request OEM Catalog
Multi-language 
IFU
Request OEM Catalog
Custom Buffer & Formulation​​​​​​​
Request OEM Catalog
Download OEM Product Catalog
QUALITY ASSURANCE
Regulatory Compliance & Trust

Our manufacturing and quality systems are audited annually against international standards, giving every OEM partner access to a compliance backbone that would take years to build independently.​​​​​​​
  • ISO 13485:2016
    Medical devices quality management system
    ​​​​​​​
  • CE-IVD Marking
    European Union market authorization
    ​​​​​​​
  • FDA Registered Facility
    510(k) cleared products available
    ​​​​​​​
  • GMP-Certified Production
    Verified cleanroom manufacturing
    ​​​​​​​
Built for Trust

BIOTEKE
Cooperation Process

Inquiry & Initial Contact

Submit the form. Our dedicated IVD account manager reviews your requirements and responds with product catalog and
pricing tiers.

NDA & Regulatory Technical Dossier

Receive official product documentation (CE/IVDR, ISO 13485) and sign a mutual NDA for custom OEM or territorial exclusivity evaluation.

Sampling & Evaluation

Order evaluation samples and rapid test kits to complete your local laboratory verification or clinical trials.

Agreement & Customization

Finalize distribution terms, territory protection, or OEM private-label packaging designs (IFU, box, cassette printing).

Production & Global Delivery

Mass production in ISO 13485 GMP cleanrooms, followed by international logistics support and ongoing marketing assets
handover.
PARTNER SUCCESS STORIES
How BioTeke Partners Grow Their Diagnostics Business
European Union · Distribution Partner
A European medical supply company wanted to differentiate their product line with a multi-pathogen respiratory test. BioTeke delivered a 5-in-1 kit (COVID/Flu A/B/RSV/ADV) with CE-IVD marking in 4 weeks, enabling the partner to capture early-season flu demand.
REQUEST
2M+
UNITS
4WKS
 DELIVERY
CE-IVD
REGULATORY STATUS
3YRS
PARTNERSHIP TERM
United States · OEM/ODM Partner
A chain brand laboratory required a freeze-dried HPV, UTI, STIs qPCR kits with private-label packaging. BioTeke's team completed formulation, stability validation and compliance documentation within 12 weeks.

REQUEST
4
SKUS
12WKS
 OEM CYCLE
500K
ANNUAL VOLUME
30DAYS
RT STABILITY
Let's Build Your Diagnostics Partnership​​​​​​​
All information shared is protected by a standard NDA

GET SOCIAL
TEL
86-510-8332 3992
ADDRESS
No.90 Huiming Road,Huishan,Wuxi City 214000,China
OPENING HOURS
work day 9:00–18:00
Cooperation Process
OEM/ODM & Private Labe l FAQs​​​​​​​
Distribution Partnership FAQs

Does BioTeke provide IVD OEM and ODM services?

Yes. BioTeke supports both OEM and ODM cooperation for selected IVD products, including private-label manufacturing, product customization, packaging, and product development based on project requirements.

Which IVD products are available for OEM/ODM?

OEM/ODM opportunities may cover selected rapid diagnostic tests, molecular diagnostic products, respiratory testing solutions, women's health/self-tests, and other products within BioTeke's development and manufacturing capabilities. Product availability depends on the intended market and project requirements.

Can we sell BioTeke products under our own brand?

Yes. BioTeke can support private-label projects for qualified business partners, subject to product availability, regulatory requirements, branding specifications, and commercial terms.

Can BioTeke customize the product or packaging?

Depending on the product, BioTeke can support customization of packaging, labeling, branding, product configuration, and other specifications. The available scope is evaluated according to the technical and regulatory requirements of each project.

Can BioTeke support regulatory documentation for OEM/ODM projects?

Yes. BioTeke can provide relevant technical and regulatory documentation available for the selected product and support partners in preparing documentation for their target market. Specific regulatory responsibilities are determined according to the product, market, and cooperation model.

What information should we provide for an OEM/ODM inquiry?

We recommend providing your target market, product or application, expected annual volume, required certifications or registrations, branding/customization requirements, and target timeline. This allows our team to evaluate the project more efficiently.

What is the typical OEM/ODM process?

A typical project follows: requirement assessment → product selection or development → technical evaluation → customization → validation → regulatory/documentation review → production → delivery. The exact process varies according to project complexity.

Can BioTeke support long-term OEM/ODM cooperation?

Yes. BioTeke is open to long-term manufacturing partnerships where product requirements, market strategy, quality expectations, and commercial conditions are aligned.

Does BioTeke work with IVD distributors and medical device importers?

Yes. BioTeke works with qualified distributors, importers, wholesalers, and other healthcare businesses interested in developing or expanding their IVD portfolios.

How does BioTeke select distribution partners?

We generally evaluate a potential partner's target market, existing product portfolio, sales and distribution capabilities, regulatory experience, customer network, projected demand, and long-term business development plans.

Can we become an exclusive distributor for BioTeke products?

Distribution arrangements are evaluated on a case-by-case basis. Any exclusivity, territory, product scope, minimum purchase requirements, and other commercial conditions depend on the market opportunity and mutually agreed partnership terms.

Does BioTeke require a minimum order quantity (MOQ)?

MOQ requirements depend on the product, packaging configuration, customization requirements, and order structure. For distributor projects, our sales team can provide the applicable commercial requirements after understanding your product and market needs.

Can distributors sell BioTeke products under the BioTeke brand?

Yes. Qualified distributors can discuss distribution of selected BioTeke-branded products. Product availability and market requirements will be evaluated according to the target country and applicable regulations.

Can distributors request private-label products?

Yes. Qualified distributors can also explore OEM/ODM and private-label opportunities where appropriate. These projects are evaluated separately according to product, market, regulatory, branding, and volume requirements.

Does BioTeke provide regulatory and technical documentation to distributors?

BioTeke can provide applicable product documentation and technical information available for the selected products. The specific documentation package depends on the product and target market.

How can we apply to become a BioTeke distribution partner?

Submit your company information, target country or territory, product interests, existing business scope, expected demand, and contact details through our partnership inquiry form. Our sales team will review the information and contact qualified prospects.

How does BioTeke protect distributor markets?

BioTeke evaluates market protection on a market-by-market basis. Where a distributor demonstrates sufficient market development capability and achieves mutually agreed commercial objectives, BioTeke may establish appropriate market protection arrangements for the agreed territory and product scope.

How does BioTeke manage distributor pricing?

BioTeke works with distribution partners to establish market-appropriate commercial pricing based on product type, order volume, market requirements, customization, logistics, and cooperation scope.
For markets with appointed partners, BioTeke seeks to maintain consistent channel pricing principles and avoid practices that unnecessarily undermine established distributor relationships.
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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