OEM / ODM · IVD Manufacturer

Your Trusted OEM / ODM Partner for IVD Rapid Tests

Progene Bio designs and manufactures colloidal-gold rapid diagnostic tests and POCT devices. 600+ SKUs across 12 series, CE-certified, shipped worldwide from our GMP facility in Nanjing.

600+Product SKUs
12Product Series
CECertified Lines
Factory Tour

Take a Look Inside Progene Bio

A short tour of our manufacturing and R&D facility.

Progene Bio IVD manufacturing facility

Click to watch our Nanjing facility tour.

What We Make

Product Series

Twelve integrated product lines covering screening, diagnosis and monitoring across human and veterinary care.

Our Strengths

Why Choose Progene Bio

A vertically integrated manufacturer built for partners who need quality, scale and flexibility.

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GMP Facility

Own state-of-the-art manufacturing with full in-house production control.

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R&D Capability

Custom formulation development for OEM / ODM projects.

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600+ SKUs

One of China's most complete rapid-test portfolios.

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Global Compliance

Deep experience with CE, FDA, FSC and international registration.

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Flexible OEM/ODM

From private labeling to full custom kit development.

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Factory Pricing

Premium quality at competitive, direct-from-factory pricing.

Compliance

Certifications & Quality

Global market access starts with rigorous, documented quality systems.

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CE Marking

EU IVDR compliant

Certified Lines
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FDA 510(k)

Selected product lines

Partial
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ISO 13485

Medical QMS

Implemented
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FSC

Free Sale Certificate

In Process
Trade Shows

News & Events

Meet Progene Bio at the world's leading diagnostics exhibitions.

Ready to build your product line?

Send us your requirements — our team responds within 24 hours with formulation options, MOQ and pricing.

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