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CDSCO UID IMP/IVD/2021/000376_8ee89a3030af8f98ee4bd9bc8e1ac63b_b3b41ee185e58a4ed45919253204d1be

CombiScreen® mALB/CREA

DiaSys Diagnostic India Private Limited·Device Class Class B·India CDSCO·Brand: CombiScreen®
Registration details
UID
IMP/IVD/2021/000376_8ee89a3030af8f98ee4bd9bc8e1ac63b_b3b41ee185e58a4ed45919253204d1be
Device class
Class B
Brand name
CombiScreen®
License holder
DiaSys Diagnostic India Private Limited
Approving authority
CDSCO
Product information
The CombiScreen® mALB / CREA urine test strip is intended to be used for the semi-quantitative determination of albumin and creatinine in human urine. This product can be used for screening samples for microalbuminuria. The mALB / CREA test strip is designed as IVD and only for professional use. It should only be done by medically trained personnel. The CombiScreen® mALB / CREA urine test strip may be evaluated visually as well as instrumentally
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About this record

CombiScreen® mALB/CREA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000376_8ee89a3030af8f98ee4bd9bc8e1ac63b_b3b41ee185e58a4ed45919253204d1be. This device is marketed under the brand name CombiScreen®. The license holder is DiaSys Diagnostic India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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