HbA1c Calibrator - India CDSCO Medical Device Registration
HbA1c Calibrator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000024_f724b0c635c1ccb9e2365eb63d047bdb_97a1c7ce77b6a3d2e3049a41e3b7a462. This device is marketed under the brand name Cystatin C Calibrator N. The license holder is Kopran Laboratories Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
Cystatin C Calibrator N
License Holder
Kopran Laboratories LimitedDevice Class
Approving Authority
CDSCO
Product Information
This product is the calibrator for the assay to determine levels of hemoglobin A1c in whole blood using NORUDIA N HbA1c on an automated analyzer
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