CDSCO UID IMP/IVD/2022/000540_5f8f870a39bba9e9d82f4791ab26971b_48baf20042cc72a2ff42869a6e712b3d

"Glycated hemoglobin analyzer"

Speedbio India Pvt. Ltd.·Device Class Class B·India CDSCO·Brand: HbA1C

Registration details

UID: IMP/IVD/2022/000540_5f8f870a39bba9e9d82f4791ab26971b_48baf20042cc72a2ff42869a6e712b3d
Device class: Class B
Brand name: HbA1C
License holder: Speedbio India Pvt. Ltd.
Approving authority: CDSCO
Product information: "An instrument intended to be used for the quantitative measurement of glycated hemoglobin (HbA1C) in a clinical specimen."

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About this record

"Glycated hemoglobin analyzer" is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000540_5f8f870a39bba9e9d82f4791ab26971b_48baf20042cc72a2ff42869a6e712b3d. This device is marketed under the brand name HbA1C. The license holder is Speedbio India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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