An IVD Certified Rapid Test — Built for Professional Distribution

CCI REAGENT is a fully documented IVD certified medical device with a stable room-temperature supply chain and defined commercial terms — designed to integrate into European healthcare procurement and distribution workflows with minimal operational complexity.

Why CCI REAGENT?

European IVD distribution covers a broad range of IVD certified devices across pharmacy, hospital, and laboratory channels. CCI REAGENT is a qualitative orientational test for elevated urinary tyrosine, certified and documented to professional distribution standards. It requires no cold chain, no laboratory infrastructure, and no specialist handling.

CCI REAGENT fits within established IVD distribution channels — pharmacy, hospital procurement, and laboratory supply networks — across Sweden, Norway, Denmark, Finland, and Iceland. The product's room-temperature storage, 36-month shelf life, and defined MOQ are aligned with standard healthcare logistics requirements in all five markets.

For distributors with established channel access to pharmacy, hospital, or laboratory procurement, CCI REAGENT offers an IVD certified product with a complete regulatory documentation pack, structured commercial terms, and full onboarding support.

Distribution Advantages

Four operational features that simplify CCI REAGENT integration into your distribution workflow.

No Cold Chain Required

CCI REAGENT is stored at room temperature (5–40 °C) with a 36-month shelf life. No refrigeration, no cold chain, and no special handling — fully compatible with standard pharmaceutical and IVD warehouse operations.

Complete Regulatory Documentation

A full IVD documentation pack is provided: Declaration of Conformity, IFU in local languages, Safety Data Sheet, technical file summary, and post-market surveillance documentation. Ready for your QA/RA team from day one.

Defined Commercial Terms

Tiered pricing based on volume commitment, transparent margin structures, defined payment terms, and territory exclusivity options. No hidden fees or retrospective adjustments. Pricing details available under NDA as part of the distributor evaluation process.

Complementary Portfolio Fit

CCI REAGENT complements existing rapid-test portfolios without displacing current product lines. As an IVD certified qualitative test for urinary tyrosine, it adds a distinct product category that is operationally straightforward to stock, handle, and distribute alongside existing IVD lines.

Explore the Commercial Fit

We are happy to discuss market data, territory analysis, and volume projections specific to your region and channel focus.

Discuss Commercial Fit Register as Distributor