About Diagen Biotechnology
Diagen Biotechnology Co., Ltd. is an in vitro diagnostics (IVD) manufacturer based in Xiamen, China, specializing in rapid test kits, ELISA kits, chemiluminescence reagents, and microsphere products for professional healthcare and laboratory use.
What We Do
We develop, manufacture, and supply diagnostic products across three main lines: one-step rapid tests (lateral flow immunoassay), ELISA kits, and chemiluminescence reagents, supported by our microsphere and magnetic microsphere product range. Our catalog covers infectious disease screening, cardiac markers, tumor markers, fertility testing, and other routine diagnostics.
Manufacturing & Quality
Production is carried out in our facility in Xiamen with an annual capacity of 20 million tests】. Our quality management system is certified to ISO 13485 / CE. Every batch is released under controlled QC procedures, and documentation for registration support is available on request.
OEM / ODM Partnership
Beyond our own brand, we provide OEM and ODM services for distributors and brand owners worldwide — from customized packaging and private labeling to full product development tailored to your market requirements.
Markets We Serve
Our products are supplied to partners across the Middle East, Africa, and Latin America. We work with medical distributors, laboratories, public health programs, and institutional buyers, and we understand the registration, documentation, and logistics requirements of these markets.
Why Partner With Us
- Factory-direct supply with stable batch-to-batch consistency
- Flexible OEM/ODM terms and low MOQ for new partners
- Registration document support (CE, COA, MSDS, free-sale certificates where applicable)
- Responsive technical and after-sales support in English
Looking for a reliable IVD manufacturing partner? Contact us or send your inquiry — we reply within one business day.