Frequently Asked Questions

No. CCI REAGENT is an orientational screening tool — an IVD certified in-vitro diagnostic device that provides a qualitative indication of elevated urinary tyrosine levels. It does not diagnose any specific condition. Positive or borderline results require confirmation through standard clinical diagnostic procedures.

Elevated urinary tyrosine levels may be associated with various metabolic or physiological conditions. CCI REAGENT does not identify or differentiate between underlying causes. Clinical interpretation and confirmatory testing are always required.

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 at room temperature (5–40 °C) in the original packaging.

No. The test consists of an ampule and an included pipette. Results are read visually against the 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.