Upper Bio-Tech

Faster, Smarter Immunoassay & Molecular Diagnostics

Trusted by Excellence

A Legacy of Innovation and Industry Leadership

400+
Patent Applications &
Intellectual Property
60+
Instruments &
Reagent Products
20+
National & Provincial
Major Projects
3
Industry Academic
Monographs
5
National, Industry &
Group Standards
About Upper Bio-Tech

Leading the Future of Smart iPOCT

Located in Zhangjiang Science City Modern Medical Device Park, Shanghai Upper Bio-Tech Co., Ltd. is a high-tech enterprise specializing in Internet+ Smart iPOCT product development, manufacturing, sales, and big data services.

National "Little Giant" Enterprise National IP Demonstration Enterprise Postdoctoral Research Station Shanghai POCT Engineering Research Center
20+
National & Provincial Major Projects
7
Scientific & Technological Awards
10+
Honors including National Key New Products
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Shanghai Upper Bio-Tech
Zhangjiang Science City · Modern Medical Device Park
Global Reach

Serving Millions of Patients Worldwide

Our products are widely used in over 1,000 healthcare institutions across domestic and international markets

1,000+
Healthcare Institutions
Covering domestic and global markets
10M+
Annual Patient Services
Serving over 10 million patients each year
60+
Instruments & Reagents
Complete rapid quantitative testing solutions
5
National & Industry Standards
Participating in industry standard development
Industry Leadership

Shaping the Future of POCT

Authored three seminal monographs that define industry standards and drive innovation in rapid diagnostics.

Instant Testing

Authored China's first POCT monograph "Instant Testing" and contributed to the establishment of National Standard GB/T 29790-2013.

Smart iPOCT

Characterized by "Precision, Automation, and Cloud-connectivity" as its three key pillars, it will better serve the future of comprehensive diagnostics and the broader cause of public health.

IVD+ Big Data Smart Diagnosis

IVD+ (In-Vitro Diagnostics & Data) is the technological integration of Diagnostics and Data. As an extension of the iPOCT (intelligent POCT) philosophy into the IVD sector, it represents the industry's strategic direction for generating and accumulating big data assets.

🏅
National & Industry Standards

Participated in establishing 5 national, industry, and group standards

Global Regulatory Compliance You Can Trust

Shanghai Upper Bio-Tech Co., Ltd. specializes in the research, development, and manufacturing of in vitro diagnostic (IVD) devices. We place product quality and patient safety at the core of our operations. Our quality management system is ISO 13485 certified, ensuring full compliance throughout the entire product lifecycle — from design and development to manufacturing and distribution.

For market access, our products comply with IVDR (EU) 2017/746 and have obtained CE marking under Notified Body A500, providing complete regulatory clearance for the European market. We also actively monitor FDA regulatory requirements, positioning ourselves for future expansion into the North American market.

With a strong regulatory foundation and a dedicated technical team, we are committed to delivering safe, reliable, and traceable IVD solutions to our global partners.

CE A500 Certification
ISO 13485 Certified
ISO 13485 Certification
CE: A500 Certification

Our Service Area

We provide comprehensive diagnostic solutions across multiple medical fields

Renal Function

Renal Panel

mALB

CRE

uTRF

RBP

α-1M

β-2M

NAG

ACR

eGFR

HbA1c

Inflammation

Inflammation Panel

SAA

CRP

PCT

HBP

IL-6

Cardiac Markers

Cardio-cerebrovascular Panel

proBNP

cTn-T

CK-MB

Myo

HFABP

D-dimer

ST2

Core Technologies of Independent R&D

Innovative solutions driving the future of diagnostics

Artificial Synthetic Biochemical Enzyme Substrate Stabilization Technology

While ensuring that the reactivity and sensitivity of the substrate remain unaffected, advanced stabilization technologies have been adopted to effectively slow down the rate of spontaneous hydrolysis of the substrate.

Broad-spectrum Anti-Agglutination Technology

By introducing nano-microsphere reagents and adopting a unique stabilization formulation, the molecular stability and anti-agglutination capability of the reagents have been effectively enhanced.

Luminescence Detection Technology

This product combines two biomarkers, ST2 and NT-proBNP, for the diagnosis and prognostic evaluation of heart failure.

Novel Mycoplasma pneumoniae Detection Technology Based on LAMP Isothermal Amplification

Through the combination of a specific primer set and lyophilized reagents, the product can be stably stored at room temperature.

Multi-Wavelength Transmission-Scattering Integrated Detection Module Technology with LED Light Source

This technology uses an LED light source as the excitation source and realizes simultaneous transmission and scattering detection of multi-wavelength spectra.

Trusted by Thousands of Hospitals

Trust Badge 3

Platforms

  • OTM-1000
  • OTM-2020
  • OTM-6000X
  • Mini+
  • Qpad
Coverage Icon

Coverage in maternal & child healthcare network

Our Journey

Company Milestones

Driving innovation and excellence since our founding

2024-2026

New Strategic Initiative

  • Expansion into AI-powered Animal & Food diagnostics
  • Expansion into international markets (Japan, Korea, Italy, Indonesia, France, UK, Israel)
2017-2023

Strengthening Independent Innovation

  • Achieved multiple national-level innovation awards and certifications
  • Continued strengthening in-house R&D and proprietary technologies
2012-2015
  • Launched the Ottoman-1000
  • Specialized in inflammation/infection testing
  • Advanced into iPOCT (Intelligent POCT) with enhanced precision, automation, and cloud integration
1997-2011

Early Development

  • Established in 1997
  • Focus on POCT solutions
  • Developed semi-automatic quantitative gold immunochromatographic analyzer
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