LumiraDx HbA1c - India CDSCO Medical Device Registration

LumiraDx HbA1c is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000449_5712142f6c0a63a0ae7f795b73786e94_9d87c9824b7deab5c0728b1ad7b70301. This device is marketed under the brand name LumiraDx CRP. The license holder is M/s Parekh Integrated Services Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

LumiraDx HbA1c

UID: IMP/IVD/2021/000449_5712142f6c0a63a0ae7f795b73786e94_9d87c9824b7deab5c0728b1ad7b70301

Brand Name

LumiraDx CRP

License Holder

M/s Parekh Integrated Services Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The LumiraDx HbA1c test is an in vitro diagnostic test for the quantitative determination of hemoglobin A1c (LumiraDx CRP) in human capillary and venous whole blood samples (LumiraDx CRP). The LumiraDx HbA1c Test Strips are intended for use with the LumiraDx Instrument. It is an automated in vitro diagnostic test for near-patient testing. HbA1c is used for the monitoring of long-term glycaemic control in individuals with diabetes mellitus, and as an aid in screening and identifying patients who may be at risk for developing diabetes. The LumiraDx HbA1c test is for Professional Use Only. For patients ≥2 years of age.