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Reagent Strip for Semi-Quantitative Determination of Microalbumin and Creatinine in Urine - India CDSCO Medical Device Registration

Reagent Strip for Semi-Quantitative Determination of Microalbumin and Creatinine in Urine is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000047_63b96ec6d32f47e80386575efd276ccf_87d4ea5c758853579a6aa4e80ddd3130. This device is marketed under the brand name DEVICE. The license holder is ORCHID BIOMEDICAL SYSTEMS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is Goa.

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CDSCO Registered
Class Class B
Reagent Strip for Semi-Quantitative Determination of Microalbumin and Creatinine in Urine
UID: MFG/IVD/2020/000047_63b96ec6d32f47e80386575efd276ccf_87d4ea5c758853579a6aa4e80ddd3130

Brand Name

DEVICE

Device Class

Class B

Approving Authority

Goa

Product Information

Biosense URS 2AC Strip is used for semi-quantitative determination of Microalbumin and creatinine in urine. Affixed to each firm plastic strip are two reagent areas that test for Microalbumin and Creatinine in urine. Measurement of the two tests at the same time from a random single-void urine sample allows for determination of the Microalbumin to Creatinine ratio (DEVICE)

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