LumiraDx INR Test Strip Kit - India CDSCO Medical Device Registration

LumiraDx INR Test Strip Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000449_617aa55da4c5fb677a7dd34b7840bb29_2f036d8dfe7e10c8f63337171b9bbc16. 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 INR Test Strip Kit

UID: IMP/IVD/2021/000449_617aa55da4c5fb677a7dd34b7840bb29_2f036d8dfe7e10c8f63337171b9bbc16

Brand Name

LumiraDx CRP

License Holder

M/s Parekh Integrated Services Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The LumiraDx INR Test Strips are intended for use with the LumiraDx Instrument. It is for use by healthcare professionals for quantitative prothrombin time testing, reported as International Normalized Ratio (LumiraDx CRP), for the monitoring of oral anticoagulation therapy with Vitamin-K Antagonist (LumiraDx CRP) drugs. The test uses fresh capillary blood. It is intended for use in patients 18 years of age or older