A CE-marked IVD self-test for the semi-quantitative detection of elevated urinary tyrosine. Designed for at-home use within preventive care pathways, with a clear path to confirmatory follow-up by a healthcare professional.
CCI REAGENT is a single-use rapid test that detects elevated levels of monohydroxyphenol metabolites (tyrosine) in a first-morning urine sample. Elevated urinary tyrosine can be associated with various physiological or pathological states. The test serves only as an orientational screening aid; clinical correlation and confirmatory testing are always required.
The test uses a colorimetric chemical reaction inside an ampule. A urine sample is added to the ampule using the included pipette; the resulting coloration is compared against the 8-shade colour reference scale enclosed in the packaging after 3–5 minutes. No laboratory infrastructure is required.
Important: CCI REAGENT is a CE-marked IVD self-test for semi-quantitative detection of elevated urinary tyrosine. It does not provide a diagnosis of cancer, any malignancy, or any specific disease. Positive, borderline, or unexpected results should be confirmed by appropriate clinical and laboratory follow-up and interpreted by a qualified healthcare professional. Negative results do not rule out the presence of any condition. Full Instructions for Use are supplied with every unit.
CCI REAGENT – in vitro diagnostic device for self-testing, designed for the detection of monohydroxyphenol metabolites (tyrosine) and its indicative amount in the patient’s urine (Lay semi-quantitative test for self-testing).
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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