CL-ELECTRODE GEN.2 - India CDSCO Medical Device Registration

CL-ELECTRODE GEN.2 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000406_b1f08ca6cb7321717de31a883662c9d9_49dc80a93cf049f3fbc0657334d11ec1. This device is marketed under the brand name C3 Fluid Pack. The license holder is Roche Diagnostics India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

CL-ELECTRODE GEN.2

UID: IMP/IVD/2019/000406_b1f08ca6cb7321717de31a883662c9d9_49dc80a93cf049f3fbc0657334d11ec1

Brand Name

C3 Fluid Pack

License Holder

Roche Diagnostics India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

The ISE module of the COBAS INTEGRA systems is intended for use in the quantitative determination of sodium, potassium, chloride in serum, plasma and urine, and lithium in serum and plasma using ion-selective electrodes

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