LumiraDx CRP Test Strips - India CDSCO Medical Device Registration

LumiraDx CRP Test Strips is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000449_0103519c888362a8f5799050a643cfe0_a31f7543e32dca8ca3ea167af72d7ec9. 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 CRP Test Strips

UID: IMP/IVD/2021/000449_0103519c888362a8f5799050a643cfe0_a31f7543e32dca8ca3ea167af72d7ec9

Brand Name

LumiraDx CRP

License Holder

M/s Parekh Integrated Services Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The LumiraDx CRP Test Strips are intended for use with the LumiraDx Instrument. It is an automated in vitro diagnostic test for near-patient testing, for use by healthcare professionals, for the quantitative determination of C-Reactive Protein in human whole blood (LumiraDx CRP) and plasma samples. The measurement of CRP provides information for the detection and evaluation of infection, tissue injury, inflammation disorders, and associated disease. It is intended for use in patients 2 years of age or older