Answers to common questions about CCI REAGENT — covering intended use, regulatory status, storage, and documentation for distribution partners.
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.
Forhøjede urinniveauer af tyrosin kan være forbundet med forskellige metaboliske eller fysiologiske tilstande. CCI REAGENT identificerer eller differentierer ikke mellem underliggende årsager. Klinisk fortolkning og bekræftende testning er altid nødvendig.
CCI REAGENT er designet til brug af sundhedspersonale og uddannet personale. I jurisdiktioner, hvor lægpersoners brug af IVD-udstyr er tilladt, er informeret selvtestning mulig med relevante instruktioner. Lovkrav varierer fra marked til marked.
36 months from the date of manufacture when stored at room temperature (5–40 °C) in the original packaging.
Nej. Testen består af en ampulle og en medfølgende pipette. Resultater aflæses visuelt mod farvereferanceskalaen. Ingen aflæser, instrument eller laboratorieudstur er nødvendig.
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.
Registrer din interesse for at modtage fuld produktdokumentation, regulatoriske filer og distributionsvilkår.
Registrer din interesse — vores partnerteam vil følge op med fuld produktdokumentation, regulatoriske filer og distributionsvilkår. Ingen forpligtelse. Fuld transparens.
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