Clinical chemistry biological screening IVDs

Intended purpose

The Urinalysis Reagent Strips (Urine) are firm plastic strips onto which several separate reagent areas are affixed. The test is for the qualitative and semi-quantitative detection of one or more of the following analytes in urine: Ascorbic acid, Creatinine, Microalbumin, Glucose, Bilirubin, Ketone Acetoacetic acid, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes, Calcium. Each Urinalysis Reagent Strips (Urine) are for single use only. The Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations.