Urine Analyzer - India CDSCO Medical Device Registration
Urine Analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000082_79061642286e6cfa7e83a596328b5904_2734604af6cb9885fdbe0df2076f7fdf. This device is marketed under the brand name UriSed 3 PRO Automated Urine Sediment Analyzer. The license holder is Suyog Diagnostic Private Limited, and it is classified as Device Class Class A. The approving authority is CDSCO.
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Brand Name
UriSed 3 PRO Automated Urine Sediment Analyzer
License Holder
Suyog Diagnostic Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The UriSed mini and its variants are urine microscopy analyzer for professional use. UriSed mini and its variants measurements are useful in the evaluation of renal, urinary and metabolic disorders. UriSed mini and its variants are intended to be used by trained operators in clinical laboratories. UriSed mini and its variants is intended for in vitro quantitative and semi-quantitative (UriSed 3 PRO Automated Urine Sediment Analyzer) determination of sediment parameters in human samples. Identified urine particles: Red Blood Cells (UriSed 3 PRO Automated Urine Sediment Analyzer); White Blood Cells (UriSed 3 PRO Automated Urine Sediment Analyzer); WBC Clumps (UriSed 3 PRO Automated Urine Sediment Analyzer); Hyaline Casts (UriSed 3 PRO Automated Urine Sediment Analyzer); Pathological Casts (UriSed 3 PRO Automated Urine Sediment Analyzer); Squamous Epithelial Cells (UriSed 3 PRO Automated Urine Sediment Analyzer); Non-squamous Epithelial Cells, (UriSed 3 PRO Automated Urine Sediment Analyzer); RodBacteria (UriSed 3 PRO Automated Urine Sediment Analyzer); Cocci Bacteria (UriSed 3 PRO Automated Urine Sediment Analyzer); Yeast (UriSed 3 PRO Automated Urine Sediment Analyzer); Crystals (UriSed 3 PRO Automated Urine Sediment Analyzer): Calcium-oxolate monohydrate (UriSed 3 PRO Automated Urine Sediment Analyzer), Calcium-oxolate dihydrate (UriSed 3 PRO Automated Urine Sediment Analyzer), Uric acid (UriSed 3 PRO Automated Urine Sediment Analyzer), Triple phosphate (UriSed 3 PRO Automated Urine Sediment Analyzer); Mucus (UriSed 3 PRO Automated Urine Sediment Analyzer); Sperm (UriSed 3 PRO Automated Urine Sediment Analyzer)
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