CDSCO UID IMP/IVD/2022/000319_1a1860cf615eb932c7930b603ed87aed_d4d56cd38c019f5c54c83a7efb7b3d23iQ®200 Urine Analyzer
- UID
- IMP/IVD/2022/000319_1a1860cf615eb932c7930b603ed87aed_d4d56cd38c019f5c54c83a7efb7b3d23
- Device class
- Class A
- Brand name
- iQ®200
- License holder
- Beckman Coulter India Private Limited
- Approving authority
- CDSCO
- Product information
- The iQ200 System is an in-vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis. Optionally, the iQ200 analyzer can be used as a stand-alone unit, or the results from the iQ200 analyzer can be combined with other urine chemistry results received from an LIS. It produces quantitative or qualitative counts of all formed sediment elements present in urine, including cells, casts, crystals, and organisms. A competent human operator can set criteria for auto-reporting and flagging specimens for review. All instrument analyte image decisions may be reviewed and overridden by a trained technologist.,iChem VELOCITY Urine Analyzer(iQ®200)-The iChem VELOCITY Automated Urine Chemistry System is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semiquantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular, they are not intended for visual reading. The iChemVELOCITY test strips are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (iQ®200) analyzer. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChemVELOCITY are intended for clinical laboratory use and in vitro diagnostic use only.
iQ®200 Urine Analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000319_1a1860cf615eb932c7930b603ed87aed_d4d56cd38c019f5c54c83a7efb7b3d23. This device is marketed under the brand name iQ®200. The license holder is Beckman Coulter India Private Limited, and it is classified as Device Class Class A. The approving authority is CDSCO.
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