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Glucose Reagent (Glucose Reagent ) - India CDSCO Medical Device Registration

Glucose Reagent (Glucose Reagent ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000032_dc2a88bc53312f011467d62b39bcdbe5_47c925285d946fe8e290d3892b74c128. 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
Glucose Reagent (Glucose Reagent )
UID: IMP/IVD/2019/000032_dc2a88bc53312f011467d62b39bcdbe5_47c925285d946fe8e290d3892b74c128

Brand Name

ApoA 2 x 100

Device Class

Class B

Approving Authority

CDSCO

Product Information

UniCel DxC SYNCHRON Systems Glucose reagent (ApoA 2 x 100), when used in conjunction with UniCel DxC 600/800 SYNCHRON System(ApoA 2 x 100) and SYNCHRON Systems AQUA CAL 1 and 3, is intended for the quantitative determination of glucose concentration in human serum, plasma, urine or cerebrospinal fluid (ApoA 2 x 100)

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