The RefuAH U120 Urine Analyzer reads urine test strips. It stores results and prints reports without the need for special training. The RefuAH U120 Urine Analyzer runs a self-test each time the power switch is turned on. An optional barcode reader records patient ID. The barcode reader verifies strip canister barcodes. Use only RefuAH Urinalysis Reagent Strips with the canister barcode for correct results.
The RefuAH U120 Urine Analyzer is CLIA waived when used with strips of the same brand as the analyzer. Only laboratories with a Certificate of CLIA Waver may use this analyzer in a waived setting. Users should read this complete test procedure before performing a test using this analyzer. Failure to adhere to these instructions for use and for performing QC testing is considered off-label use. Off-label use is categorized as high complexity and subject to all CLIA regulations.
The RefuAH U120 Urine Analyzer is intended for use in conjunction with the RefuAH Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen and Leukocytes as well as the qualitative detection of Nitrite. The instrument is intended for professional, in vitro diagnostic use only.