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<span style="font-size:20px;"><span style="color:#ffffff;"><strong>20+</strong></span></span>
<span style="font-size:20px;"><strong>100+</strong></span>
<span style="font-size:20px;"><strong>200+</strong></span>
<span style="font-size:20px;"><strong>ISO 13485</strong></span>
WHY CHOOSE BIOTEKE 
Built for Partners​​​​​​​ Who Need More Than a Manufacturer
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
     MOQ as low as 10,000 units 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
A Structured Path from Brief to Shelf

1
Needs Assessment
Initial consultation to define target markets, product specs, volume, and regulatory pathways
2
Proposal & Agreement
Customized proposal with product selection, pricing, timelines, and NDA / OEM agreement signing
3
Customization & Design 
Packaging artwork, label design, IFU creation, and formulation adjustment to approved specifications
4
Sample & Validation
Pre-production samples dispatched within 15 days; partner-led validation and approval sign-off
5
Regulatory Filing
Technical file compilation, CE declaration, FDA registration, or country-specific dossier preparation

6
Mass Production & Delivery
GMP production, QC batch release, export documentation, and logistics coordination to your warehouse

Multiple SKUs Across Diagnostic Categories
Respiratory Rapid Antigen Tests
view more
Fertility Rapid Tests
view more
Molecular Diagnostics (PCR / qPCR)​​​​​​​ Kits
view more
Laboratory Supplies
view more
Download OEM Product Catalog
​​​​​​​
QUALIFICATIONS
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

​​​​​​​
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 9:00–17:00
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