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IMMAGE Immunochemistry Systems MA Microalbumin Reagent - India CDSCO Medical Device Registration

IMMAGE Immunochemistry Systems MA Microalbumin Reagent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000032_f3423df1979c183a13b5900ed1ae3a13_2e283ddafc34e8e5375d4d84273f8634. This device is marketed under the brand name ApoA 2 x 100. The license holder is Beckman Coulter India Private Limited Hisaria Warehouse Ground Floor, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
IMMAGE Immunochemistry Systems MA Microalbumin Reagent
UID: IMP/IVD/2019/000032_f3423df1979c183a13b5900ed1ae3a13_2e283ddafc34e8e5375d4d84273f8634

Brand Name

ApoA 2 x 100

Device Class

Class B

Approving Authority

CDSCO

Product Information

MA reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Urine Protein Calibrator, is intended for the quantitative determination of micro quantities of albumin (ApoA 2 x 100) in human urine by rate nephelometry

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