IVD Testing System for Qualitative or Semi-Quantitative Analysis of Urine Parameters, and Quantitative and Qualitative Analysis of Urine Sediment - Vietnam Registration 240001124/PCBB-HN

The urine sediment analyzer is applicable for quantitative and qualitative analysis of urine sediment. In addition, the analyzer can be used in combination with urine dipstick to perform semiquantitative or qualitative analysis of biochemical components in urine samples. The test parameters of urine sediment include: RBC, DRBC (G1, Coin, Ghost), WBC, WBCC, SQEP, NSQEP, HYA, PAT (GRAN, WAXY, CELL), CAOX (CaOxm, CaOxd), URIC, STRUVITE, AMOR, OTCRY (CaPh), BACT (Cocci, Scoccus, Bacilli), YST, MUCS, SPRM, OTHER. In addition, the biochemical parameters of urine include: Ascorbic acid, Nitrite, Microalbumin, Leukocytes, Creatinine, Ketone, Urobilinogen, Bilirubin, Glucose, Protein, Specific Gravity, pH, Blood, Calcium, and the ratio of Microalbumin/Creatinine (ACR), the ratio of Protein/Creatinine Ratio (PCR). The analyzer can also perform physical parameter tests: Specific Gravity, Color, Turbidity, Osmotic Pressure, and Conductivity. The analyzer can also be used to analyze cerebrospinal fluid (RBC, WBC), pleural effusion (RBC, WBC) and vaginal discharge (RBC, WBC, EP, BACT). The Urit 14FA urine dipstick provides semiquantitative tests for ascorbic acid, nitrite, microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, pH, blood, and calcium in urine. Please refer to the package insert or the vial label to determine which tests are included in the product you are using. It is intended to be used in combination with the Urit-1550, Urit-1560, Urit-1600, Urit-1610, Urit-1600PLUS, UC-1800, UC-1810, Urit-560, UC-58, UC-580 and AI-Libre US -1680, US-1681 urine analyzers. The Urit urine dipstick is intended for in vitro diagnostic use by qualified professionals at centralized laboratory sites. The dipstick is designed for use in the following patient risk groups to support diagnosis in the following areas: · Renal function · Urinary tract infection · Carbohydrate metabolism (e.g., diabetes) · Liver function Urine biochemical tests are intended to be used as a screening test and should not be used as a stand-alone diagnostic test. The Urit UQ-14 quality control material is intended for use with urine analyzers and urine dipsticks to control the quality of urine tests. URIT QC 22: The low concentration quality control material (level 1) is intended to monitor the accuracy of the urine sediment analyzer. The medium concentration quality control material (level 2) is intended to monitor the accuracy of the urine sediment analyzer. The high concentration quality control material (level 3) is primarily intended to monitor the accuracy of the urine sediment analyzer. URIT CA 21 is intended to calibrate the WBC and RBC modules and to monitor or evaluate the accuracy of the urine sediment analyzer test results. URIT YC 2ST is intended for in vitro diagnostic use to calibrate the density and turbidity modules of the Urit series of automated urine analyzers, the UC series of automated urine analyzers and the US series of automated urine analyzers. Correspond