LumiraDx D-Dimer Test Strip Kit - India CDSCO Medical Device Registration

LumiraDx D-Dimer Test Strip Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000449_efc0464e670015e6f97722d9f0be7942_b1cf199ea9738d0ca996c26139e791c1. 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 D-Dimer Test Strip Kit

UID: IMP/IVD/2021/000449_efc0464e670015e6f97722d9f0be7942_b1cf199ea9738d0ca996c26139e791c1

Brand Name

LumiraDx CRP

License Holder

M/s Parekh Integrated Services Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The LumiraDx D-Dimer Test is an in vitro diagnostic test for the quantitative determination of D-Dimer in human capillary and venous whole blood and plasma samples (LumiraDx CRP). The LumiraDx D-Dimer Test Strips are intended for use with the LumiraDx Instrument. It is an automated in vitro diagnostic test for near-patient testing to aid in the assessment and diagnosis of patients with suspected venous thromboembolism (LumiraDx CRP) such as deep vein thrombosis (LumiraDx CRP) and pulmonary embolism (LumiraDx CRP). The Test can be used in conjunction with a clinical pre-test probability assessment model to exclude deep vein thrombosis (LumiraDx CRP) and pulmonary embolism (LumiraDx CRP) disease in patients suspected of DVT or PE. The LumiraDx D-Dimer Test is for Professional Use Only. For patients ≥18 years of age