Description
SDS-Clarity-Urocheck
Urocheck Analyzer Package Insert
10SG-Package Insert
MSDS-10SG
Contents: Analyzer, 5 (five) bottles of 10SG strips, package insert
The Clarity Urocheck 120C Urine Analyzer reads urine test strips. It stores results and prints reports without the need for special training. The Clarity Urocheck 120C 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 Clarity Urinalysis Reagent Strips with the canister barcode for correct results. The Clarity Urocheck 120C Urine Analyzer is CLIA waived when used with the Clarity Urinalysis Reagent Strips. Only laboratories with a Certificate of CLIA Waiver 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.
Intended Use
The Clarity Urocheck 120C Urine Analyzer is intended for use in conjunction with the Clarity Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes, as well as the qualitative detection of Nitrite. The instrument is intended for professional, in vitro diagnostic use only. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract
HIGHLIGHTS
- CLIA Waived
- QC and Operator LOCKOUT
- Throughput of 120 tests per hours
- Provides automated readings for Clarity Brand Strips: DTG-2GP, DTG-4OB, DTG-5OB, DTG-URO7, DTG-10SG and CD-MAC25 (Microalbumin/Creatinine)
- Compatible with ALL LIS, HIS, EMR, and EHR systems
- Placement program AVAILABLE
- Auto feed mechanism for printer paper loading
- Compatible with regular thermal paper (DTG-UAPPR) or sticky thermal paper (DTG-UASPPR) for labeling patient reports with results
- Light weight and compact, ideal for point-of-care and physicians office setup
- Accurate, precise, fast and easy-to-use
- Large LCD display
- Auto calibration and self-check
- Flagging of abnormal patient results
- Internal memory capable of storing 2000 tests
- RS 232 port or USB for connectivity
- Bar-code reader (optional, DTG-UABC)
