An IVD certified in-vitro diagnostic device for qualitative detection of elevated tyrosine levels in urine. Intended for professional use by healthcare professionals or trained laboratory personnel within a validated care pathway.
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 qualitative in-vitro diagnostic aid intended exclusively for professional use by healthcare professionals or trained laboratory personnel (lay self-testing only where permitted by national law). The test detects elevated urinary tyrosine levels but does not provide a diagnosis of cancer, any malignancy, or any specific disease. Positive, borderline or unexpected results must always be confirmed by appropriate standard clinical and laboratory diagnostic procedures. Negative results do not rule out the presence of any condition. Results must be interpreted by a qualified physician in the full clinical context.
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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