IVD Certified Tyrosine Tester

An IVD Rapid Test Kit Built for Scalable Distribution

CCI REAGENT measures urinary tyrosine levels in under 5 minutes. Clear documentation. Predictable supply. Fast distributor onboarding across Europe.

We do not sell directly to consumers. We work with approved distribution partners.

CCI REAGENT rapid tyrosine screening test kit

< 5 min

Result Time

Visual colour-scale reading. No lab equipment required.

IVD

Certified Medical Device

Full regulatory documentation available. IVDR-ready pathway defined.

36-month

Shelf Life

Room temperature storage. MOQ and palletization defined.

CCI REAGENT test kit â€” packaging and strip detail

Precision in Every Ampule

Qualitative colour-scale IVD test for elevated urinary tyrosine
Visual result in under 5 minutes — no lab equipment required
Room-temperature storage. 36-month shelf life. Defined MOQ and palletization.
IVD certified — full regulatory documentation available on request

Orientational screening aid for professional use within a validated care pathway. Not intended for self-diagnosis or standalone clinical decision-making.

View Full Product Specification →

Three Steps. Under Five Minutes.

Collect Sample

Collect a fresh first-morning urine sample. For 48 hours before testing, avoid high-protein foods, tyrosine supplements, and medications that may affect the result. See the full Instructions for Use for preparation details.

Apply Reagent

Add the urine sample to the CCI REAGENT ampule using the included pipette. The reaction begins immediately.

Read Result

Compare the colour of the reagent against the colour reference scale enclosed in the packaging within 5 minutes. Document the result.

View Detailed Instructions →

Designed for Procurement and Compliance Workflows — Not Marketing Narratives

We built our distributor programme around the operational realities of European healthcare distribution. Every aspect — from regulatory documentation to logistics and onboarding — is structured to reduce your risk and workload.

Regulatory Readiness

Complete IVD documentation pack. IFU variants available. Post-market surveillance process defined.

Operational Simplicity

Defined MOQ, palletization specs, and lead times. Stable supply chain with no seasonal disruption.

Onboarding Support

Sales training kit, product explainers, and localized marketing assets provided. Dedicated partner manager for the first 90 days.

Market Opportunity

CCI REAGENT offers a fully documented IVD certified rapid test with a stable, room-temperature supply chain. Transparent commercial terms, defined MOQ, and a complete regulatory documentation pack reduce operational risk for distributors adding a new qualitative test to their portfolio.

Discuss European Distribution →

Partner-Ready from Day One

Our partnership process is structured and transparent. From NDA to first order, we guide you through every step — regulatory, logistical, and commercial.

Documented Full IVD + ISO regulatory pack

Scalable Defined SKU, MOQ, and pallet configuration

Supported Onboarding kit, training assets, partner manager

Start the Partnership Process →