Frequently Asked Questions

No. CCI REAGENT is an orientational IVD self-test that indicates the approximate amount of tyrosine in urine. It does not diagnose any specific condition. Every result must be discussed with a physician, who decides on any further examination.

Tyrosine levels in urine can be affected by a range of metabolic and physiological conditions, as well as by diet and medication. CCI REAGENT does not identify or differentiate between underlying causes. Interpretation belongs to a physician.

CCI REAGENT is designed for use by healthcare professionals and trained personnel. In jurisdictions where lay use of IVD devices is permitted, informed self-testing is possible with appropriate instructions. Regulatory requirements vary by market.

36 months from the date of manufacture when stored dry and closed at 5–40 °C.

No. The test consists of a glass ampule and an included pipette. The result is read visually against the 8-shade colour reference scale. No reader, instrument or laboratory infrastructure is needed.

We provide a complete IVD documentation pack including: Declaration of Conformity, IFU (Instructions for Use), Safety Data Sheet, technical file summary, and performance data references. Available upon request or through the distributor portal.

Yes. We offer OEM and private label configurations. Packaging, labeling, and IFU can be adapted to distributor branding within regulatory requirements. Details are covered in the distributor partnership process.

Results should be recorded as negative, borderline, or positive according to the colour reference scale, along with the test date, lot number, and patient/sample identifier. A result documentation template is included in the distributor onboarding kit.