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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.

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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.

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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.

View 5-in-1 Kit → Get Pricing
200+
Product SKUs
80+
Countries Served
15+
Years in IVD
ISO
13485 Certified
✓
CE IVDD / IVDR
✓
FDA EUA Authorized
✓
ISO 13485:2016
✓
WHO EUL Listed
✓
TGA Australia
✓
MDSAP Compliant
✓
Health Canada
✓
GMP Certified
✓
CE IVDD / IVDR
✓
FDA EUA Authorized
✓
ISO 13485:2016
✓
WHO EUL Listed
✓
TGA Australia
✓
MDSAP Compliant
✓
Health Canada
✓
GMP Certified
🔬 Full Catalog

Product Portfolio

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

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🤧
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 →
Why ProACCU

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.
2009
Founded
About Us

Science-Driven.
Patient-Focused.

ProACCU Biotech Co., Ltd is a leading manufacturer of in-vitro diagnostic (IVD) rapid test kits headquartered in China. With over 15 years of expertise, we serve distributors, hospitals, and government agencies across 80+ countries.

✓
50,000+ sq.ft GMP manufacturing facility — meeting international production standards with full traceability.
✓
200+ product SKUs across 8 diagnostic categories — one partner for all your IVD needs.
✓
CE, FDA, ISO 13485, WHO EUL and additional global regulatory approvals.
✓
Dedicated ODM/OEM team — your brand, our expertise. Fast turnaround, competitive pricing.
Get in Touch → Download Brochure
🤝 Partnerships

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
📰 Updates

ProACCU News & Insights

All Articles →
📰
Company News May 15, 2026
ProACCU Launches Next-Generation 5-in-1 Respiratory Combo Kit with Enhanced Sensitivity
Our new flagship 5-in-1 panel achieves 98.5% sensitivity for all five targets simultaneously, setting a new industry benchmark for multi-pathogen point-of-care diagnostics...
🏆
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...
💬 Get In Touch

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
sales@proaccu.com
💬
WhatsApp / WeChat
+86-XXX-XXXX-XXXX
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