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510(k) Data Aggregation
K Number
K182038Device Name
URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
Manufacturer
YD Diagnostics Corporation
Date Cleared
2018-12-10
(133 days)
Product Code
JFY, CEN, JIL, JIN, JIO, JIR, JMT, JRE, KQO, LJX
Regulation Number
862.1225Why did this record match?
Applicant Name (Manufacturer) :
YD Diagnostics Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The URiSCAN 10 ACR urine strips on the URiSCAN Optima urine analyzer are intended for the in vitro qualitative and semi-quantitative measurement of the following parameters: blood, ketones (acetoacetic acid), protein, nitrite, glucose, pH, SG (specific gravity), leucocytes, albumin and the determination of the ACR (albumin creatinine ratio). These measurements are useful in the evaluation of renal, urinary and metabolic disorders.
The URiSCAN Optima urine analyzer is intended to read the color change on the test pads found on the URiSCAN 10ACR urine strips and to display and print the results.
The URiSCAN 10ACR urine strips include test pads for the following parameters: blood, ketones (acetoacetic acid), protein, nitrite, glucose, pH, SG (specific gravity), leucocytes, albumin and can only be read on the URiSCAN Optima urine analyzer.
The URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer are intended for prescription use only, in clinical laboratory and in point-of-care settings.
Device Description
The URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer are intended for the in vitro qualitative and semi-quantitative measurement of the following parameters: blood, ketones (acetoacetic acid), protein, nitrite, glucose, pH, SG (specific gravity), leucocytes, albumin and the determination of the ACR (albumin creatinine ratio). The URiSCAN Optima urine analyzer is intended to read the color change on the test pads found on the URiSCAN 10ACR urine strips and to display and print the results. The URiSCAN 10ACR urine strips include test pads for the following parameters: blood, ketones (acetoacetic acid), protein, nitrite, glucose, pH, SG (specific gravity), leucocytes, albumin and can only be read on the URiSCAN Optima urine analyzer.
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