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CombiScreen® mALB/CREA - India CDSCO Medical Device Registration

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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class B
CombiScreen® mALB/CREA
UID: IMP/IVD/2021/000376_8ee89a3030af8f98ee4bd9bc8e1ac63b_b3b41ee185e58a4ed45919253204d1be

Brand Name

CombiScreen®

Device Class

Class B

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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