Frequently Asked Questions
What products do you manufacture?
IVD rapid tests and POCT devices — colloidal-gold lateral-flow and fluorescence immunoassay. 600+ SKUs across 12 series: drug of abuse, infectious disease, cardiac & tumor markers, women's health, veterinary and more.
Do you offer OEM / ODM?
Yes — private label, custom analyte panels, custom cut-offs, packaging and IFU. See the OEM/ODM page for capabilities and commercial terms.
What certifications do you hold?
CE marking (self-declaration under IVDD 98/79/EC), ISO 13485:2016 (GB/T 42061), and China NMPA registration. See the certifications page for details and certificate numbers.
What is your MOQ?
Product-dependent — low MOQ is available on specialty assays. Confirm your specific MOQ and lead time via RFQ.
Can I request samples?
Yes — samples are available for evaluation. Request via the RFQ form or contact us.
Do you provide documentation (IFU, datasheet)?
Yes — IFU, datasheet, validation, COA and CE technical files are available on request for buyer qualification.
Do you ship internationally?
Yes — we export worldwide with full export documentation per destination.
How do I become a distributor?
Submit an RFQ with your target market and volume — our export team responds within one business day.