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Semi-automatic Urine analyser / test strip reader - India CDSCO Medical Device Registration

Semi-automatic Urine analyser / test strip reader is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000206_db0559a472c67395de3632dc9bfd7d48_5de181c74cdb3a6dfe455bae52c56186. This device is marketed under the brand name HumaCLIA 150 . The license holder is M/s Stedman Pharmaceuticals Pvt. Ltd., and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered
Class Class A
Semi-automatic Urine analyser / test strip reader
UID: IMP/IVD/2019/000206_db0559a472c67395de3632dc9bfd7d48_5de181c74cdb3a6dfe455bae52c56186

Brand Name

HumaCLIA 150

Device Class

Class A

Approving Authority

CDSCO

Product Information

Combilyzer13 is a semi-automatic urine test strip reader to be used together with COMBINA 13 urine test strip. It provides a qualitative or semi-quantitative result for urobilinogen, microalbumin, bilirubin, ketones, creatinine, blood, protein, nitrite, leukocytes, glucose, specific gravity, pH and vitamin C of the urine sample according to the colour change caused by the interaction between the reagent areas and the biochemical components in urine

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