Trusted by 80+ Countries

Precision Diagnostics
for a Healthier World

ProACCU Biotech delivers CE/FDA-approved rapid test kits with industry-leading accuracy. From respiratory panels to cardiac markers — built for global healthcare.

ISO 13485 Certified

ODM / OEM
Solutions at Scale

Custom branding, private label, and OEM/ODM partnerships available. Partner with us to bring your branded diagnostic products to market faster.

5-in-1 Combo Kit Available

Multi-Pathogen
Detection Simplified

Our flagship 5-in-1 combo kit detects COVID-19, Flu A&B, RSV and Adenovirus simultaneously — one sample, one device, minutes to result.

200+
Product SKUs
80+
Countries Served
15+
Years in IVD
ISO
13485 Certified
Respiratory
Women Health
Infectious Disease
Drug of abuse
Cardiac Markers
Tumor Markers
Urine Analyzer Reagent
Elisa & DOT Test
Veterinary Test
Respiratory
Women Health
Infectious Disease
Drug of abuse
Cardiac Markers
Tumor Markers
Urine Analyzer Reagent
Elisa & DOT Test
Veterinary Test

Product Portfolio

8 diagnostic categories covering infectious disease, women's health, cardiac markers, and more.

View All Products →
🤧
NEW
Respiratory
Influenza A&B + COVID-19 Combo
15 minNasal SwabCE
Learn More
🫁
Respiratory
RSV Antigen Rapid Test
20 minNPSCE
Learn More
🫀
Cardiac Markers
D-Dimer Rapid Quantitative Test
15 minBloodCE
Learn More
🧬
Women's Health
HCG Pregnancy Rapid Test
5 minUrineCE
Learn More
🦟
Tropical Infectious
Malaria P.f/P.v Combo Rapid Test
20 minBloodCE
Learn More
🌡️
Tropical Infectious
Dengue NS1 Ag + IgG/IgM Combo
20 minSerumCE
Learn More
🔬
Intestinal Disease
H. Pylori Stool Antigen Test
10 minStoolCE
Learn More
💊
HOT
Drug of Abuse
Multi-Drug 10-Panel Urine Test
5 minUrineFDA
Learn More

Engineered for Accuracy.
Built for Scale.

Every product we manufacture meets the highest international standards — because your patients deserve nothing less.

🎯
Superior Accuracy
Sensitivity ≥97% and Specificity ≥99% across our flagship product lines. Backed by clinical validation studies in multiple countries.
Rapid Results
Most kits deliver results in 10–20 minutes. Designed for point-of-care environments where time is critical.
🏭
Large-Scale Manufacturing
50,000+ sq.ft GMP facility with capacity to produce millions of units monthly. Government procurement-ready supply chain.
🌍
Global Compliance
CE, FDA, WHO EUL, TGA, MDSAP, Health Canada — our products are approved for sale in 80+ countries.
🔬
R&D Innovation
Dedicated R&D team of 60+ scientists continuously developing next-generation assay technologies.
🤝
ODM / OEM Flexibility
Custom formulations, white-label packaging, and dedicated project managers for OEM/ODM partnerships of any scale.

Interpreting Life with Science and Technology, Achieving Health with Care.

Who We Are

ProACCU Biotech Co., Ltd. is a biotechnology company specializing in research, development and manufacturing of advanced medical in-vitro diagnostic (IVD) rapid test kits, medical and laboratory disposable products. We provide one-step medical diagnostic rapid test kits under our ProACCU brand. Products include Fertility Tests, Infectious Diseases, Tumor Markers, DOA Drug of Abuse Test, Drug Test Cup, Urinalysis Reagent Strip, ELISA Kit, Digital Alcohol Tester, Urine Analyzer, and more.

Our focus is to expand our markets internationally by forming strategic alliances and entering into partnerships with distributors worldwide. We have established an international reputation for excellence in the manufacturing of quality medical and laboratory products. We have obtained approval licenses ISO 13485, FSC certificate, and most of our products carry the CE mark.

Our objective is the utmost satisfaction of our clients all around the world by supplying quality and economical products.

It is the policy of ProACCU Biotech Co., Ltd. to achieve the highest degree of product quality, ensuring that processes and services are continually improved in line with customer requirements.

🏢 Our Facility

Product Fields

Our products cover multiple medical testing fields, with stable quality and full traceability.

🫁
Respiratory Infectious Diseases
🦠
Sexually Transmitted Diseases
🔬
Digestive Diseases
🦟
Tropical Infectious Diseases
🎗️
Tumor Markers
🫀
Myocardial Markers
👶
Maternal and Child Health
💊
Drug of Abuse
2009
Established
80+
Countries Served
200+
Product SKUs
ISO
13485 Certified
🏭

Advanced Facilities

100,000-class temperature and humidity controlled cleanrooms with P2 biosafety laboratories

🤖

Intelligent Production

Advanced production lines integrated with intelligent logistics systems

Quality Assurance

EN ISO 13485:2016 compliant with full traceability from raw materials to finished products

Quality Certifications

ProACCU has passed multiple international quality system certifications, ensuring regulatory compliance for global market access.

🇪🇺
CE
European Conformity
🇺🇸
FDA
US FDA Registered
🇦🇺
TGA
Australia
🇸🇬
HSA
Singapore
🌐
MDSAP
Medical Device Single Audit
🌍
WHO EUL
WHO Emergency Use
🇹🇼
TFDA
Taiwan
🇲🇾
MDA
Malaysia

Our Mission & Values

🎯

Mission

To let people know their health status, enabling anytime, anywhere self-testing. We provide the best products and services to our customers while contributing to a better society.

Core Values

  • Integrity — Honesty in every interaction
  • Quality — Excellence in all we do
  • Innovation — Continuous improvement
  • Partnership — Mutual success focus
🤝

Commitment

Creating a lively and challenging working environment to explore the full potential of our staff. Building lasting partnerships based on trust, transparency, and shared growth.

What Our Clients Say

Trusted by laboratories and healthcare providers worldwide for accuracy, speed, and ease of use.

★★★★★
ProACCU kits are a game-changer for our lab. Results are consistent and the customer support is exceptional. We've standardized all our rapid tests on their platform.
RK
Dr. Rajesh Kumar
Lab Director, MedPath Diagnostics
★★★★★
We've been distributing ProACCU products across East Africa for 5 years. Their 5-in-1 respiratory combo is our top seller — patients love the speed and doctors trust the accuracy.
AS
Amina Said
CEO, HealthServe Tanzania
★★★★★
The OEM partnership with ProACCU has been seamless. Custom packaging, regulatory support, and consistent quality — exactly what we needed to expand our brand across Southeast Asia.
MT
Michael Tan
Product Manager, BioCare Asia

How We Work With You

Flexible partnership models designed for distributors, healthcare institutions, and branded product companies.

🏷️
OEM / Private Label
Your brand on our proven products. Full packaging customization, language localization, and regulatory support for your target market.
  • Custom branding & packaging design
  • Regulatory filing assistance
  • Low MOQ for market entry
  • Dedicated account manager
🔬
ODM Development
Custom assay development tailored to your exact specifications. Our R&D team works with you from concept to regulatory submission.
  • Custom antigen / antibody development
  • Formulation & performance optimization
  • Clinical trial coordination
  • CE / FDA technical file preparation
🌐
Distribution Partnership
Become an authorized ProACCU distributor in your region. Exclusive territory rights, marketing support, and training included.
  • Regional exclusivity available
  • Marketing materials & demos
  • Technical training & support
  • Priority production allocation

ProACCU News & Insights

All Articles →
🏆
Exhibition Apr 20, 2026
ProACCU Highlights at Medica 2026 in Düsseldorf
Our team showcased 12 new products at the world's premier medical trade show...
🌍
Industry Mar 8, 2026
Rapid Diagnostics Market to Reach $12B by 2027 — How ProACCU Is Positioned
Global IVD market growth and how our expanded product pipeline addresses emerging testing demand...

Have Questions?
We Reply Within 24h.

Whether you're looking for product samples, pricing, regulatory documentation, or a long-term ODM partnership — our team is ready to help.

📍
Headquarters
ProACCU Biotech Co., Ltd
[Address, City, Province, China]
📞
Phone
+86-XXX-XXXX-XXXX
Email
info@proaccu.com
💬
WhatsApp / WeChat
+86-XXX-XXXX-XXXX
Request a Free Sample or Quote

🔒 Your information is secure and will never be shared. We respond within 24 business hours.

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