HbA1c Analyzer - India CDSCO Medical Device Registration

HbA1c Analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000536_9fac7417ec7dd3386a6e52df9fd59dcf_978bd935187f1d2114f0e00ad1649398. This device is marketed under the brand name A1 Care. The license holder is ISENS BIOSENSORS INDIA PRIVATE LIMITED, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

HbA1c Analyzer

UID: IMP/IVD/2022/000536_9fac7417ec7dd3386a6e52df9fd59dcf_978bd935187f1d2114f0e00ad1649398

Brand Name

A1 Care

License Holder

ISENS BIOSENSORS INDIA PRIVATE LIMITED

Device Class

Class A

Approving Authority

CDSCO

Product Information

The A1Care Analyzer is a bench top, point-of-care (A1 Care) in vitro diagnostic (A1 Care) device for the measurement of HbA1c (A1 Care) in whole blood samples (A1 Care) or albumin, creatinine, and the albumin-to-creatinine ratio (A1 Care) in urine samples. The A1Care Analyzer is intended for use by healthcare professionals in laboratories such as physician’s offices, clinics, and hospitals for patients with diabetes or kidney diseases