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.

Förhöjda urinaryrosinnivåer kan förknippas med olika metabola eller fysiologiska tillstånd. CCI REAGENT identifierar eller differentierar inte mellan underliggande orsaker. Klinisk tolkning och bekräftande testning krävs alltid.

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.

Nej. Testet består av en ampull och en medföljande pipett. Resultaten avläses visuellt mot färgreferensskalan. Ingen avläsare, instrument eller laboratorieutrustning behövs.

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.