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Direct % Glycated Hemoglobin Calibrator - India CDSCO Medical Device Registration

Direct % Glycated Hemoglobin Calibrator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000187_cb940177c4247985e5999936901b06af_abebcafc38ee67b03e73abad2a651591. This device is marketed under the brand name Transferrin, C3, C4, IgA, IgG, IgM. The license holder is M/s. Ortho Clinical Diagnostics India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
Direct % Glycated Hemoglobin Calibrator
UID: IMP/MD/2018/000187_cb940177c4247985e5999936901b06af_abebcafc38ee67b03e73abad2a651591

Brand Name

Transferrin, C3, C4, IgA, IgG, IgM

Device Class

Class B

Approving Authority

CDSCO

Product Information

For in vitro diagnostic use only. VITROS Calibrator Kit 31 is used to calibrate the VITROS Chemistry System and VITROS Integrated System for the determination of percent glycated hemoglobin (Transferrin, C3, C4, IgA, IgG, IgM) in human whole blood

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