The Healgen® Series Urine Reagent Strips (URS) and Urine Analyzers are in vitro test systems intended for qualitative and semi-quantitative analysis of the parameter listed in the following table.
The Healgen® Series Urine Reagent Strips (URS) and Urine Analyzers are intended for use to detect conditions indicating possible diabetes, metabolic abnormalities, liver diseases, kidney function, and urinary tract infections.
Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.
| Test Item | Cut-off Value | Kit Size | Regulatory Clearance |
|---|---|---|---|
| Ascorbate | 0.5-0.6 mmol/L | 100 | 510(k), CE |
| Bilirubin | 8.6-17 μmol/L | 100 | 510(k), CE |
| Blood | 5-15 Ery/μL | 100 | 510(k), CE |
| Ca | 2.5 mmol/L | 100 | CE |
| Creatinine | 50 mg/dL | 100 | CE |
| Glucose | 2.8~5.5 mmol/L | 100 | 510(k), CE |
| Ketone | 0.5~1.0 mmol/L | 100 | 510(k), CE |
| Leukocytes | 5-15 Leuko/μL | 100 | 510(k), CE |
| Micro Albumin | 0.08~0.15 mg/dL | 100 | CE |
| Nitrite | 13~22 μmol/L | 100 | 510(k), CE |
| pH | 0.5 | 100 | 510(k), CE |
| Protein | 0.15~0.3 g/L | 100 | 510(k), CE |
| Specific Gravity | 0.005 | 100 | 510(k), CE |
| Urobilinogen | 3.3-16 μmol/L | 100 | 510(k), CE |
