An IVD self-test for semi-quantitative detection of elevated tyrosine levels in urine. An orientational result the user brings to their physician.
CCI REAGENT is a single-use test that detects monohydroxyphenol metabolites (tyrosine) in a first-morning urine sample. It indicates the approximate amount of tyrosine present; it does not identify a cause.
The test uses a chromogenic chemical reaction inside a glass ampule, based on an improved Millon's reagent method. Urine is added to the ampule with the included pipette and the resulting colour is compared against the 8-shade reference scale supplied in the pack after 3–5 minutes. No instrument or laboratory infrastructure is required.
Important: CCI REAGENT is an orientational self-test. It does not provide a diagnosis of any disease or condition. Every result, and particularly a positive or unexpected one, must be discussed with a physician, who decides on any further examination. Sensitivity can be affected by urine composition, diet and medication.
CCI REAGENT is an in vitro diagnostic medical device for self-testing, intended to detect monohydroxyphenol metabolites (tyrosine) and their indicative amount in the user's urine. It is a semi-quantitative orientational test for lay users aged 18 and over, performed at home. The result is orientational only and must be discussed with a physician.
The test is not intended as a standalone diagnostic tool. Results should be interpreted in the context of clinical history and confirmed by appropriate laboratory methods.
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