Choosing the right IVD Reagents OEM/ODM partner in China can make or break your diagnostic product launch. Here is the ultimate 2026 checklist:
1. Check Certifications: Ensure they have NMPA, CE, or FDA compliance track records.
2. Microfluidic Expertise: Do they have in-house molding and microfluidic chip design capabilities?
3. Advanced Assays: Look for expertise in Time-Resolved Fluorescence (TRF) and rapid two-step PCR.
4. Quality Control: Verify their batch-to-batch consistency and stability testing protocols.
5. Supply Chain: A true POCT manufacturer should control both the hardware and the reagent supply chains.