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Hemoglobin HbA1c Test Kit(Hemoglobin HbA1c Test Kit ) - India CDSCO Medical Device Registration

Hemoglobin HbA1c Test Kit(Hemoglobin HbA1c Test Kit ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000047_b1ca1499088c6e3ccf4cc8271f76fbcf_92a58697281c1c449d253b4ce1a24375. This device is marketed under the brand name Boronate Affinity. The license holder is Microgene Diagnostic Systems (p) Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
Hemoglobin HbA1c Test Kit(Hemoglobin HbA1c Test Kit )
UID: IMP/IVD/2023/000047_b1ca1499088c6e3ccf4cc8271f76fbcf_92a58697281c1c449d253b4ce1a24375

Brand Name

Boronate Affinity

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Hemoglobin A1c Test Kit (Boronate Affinity) (Boronate Affinity) adopt the principle of boronate affinity to use with the LD-100 POCT HbA1c Analyzer to detect the content of glycosylated hemoglobin in the human whole blood samples, mainly for diagnosis of diabetes and monitoring of blood glucose level in clinical practice.

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DJ Fang

DJ Fang

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