LumiraDx D-Dimer Test Strip Kit
- UID
- IMP/IVD/2021/000449_efc0464e670015e6f97722d9f0be7942_b1cf199ea9738d0ca996c26139e791c1
- Device class
- Class C
- Brand name
- LumiraDx CRP
- License holder
- M/s Parekh Integrated Services Pvt. Ltd.
- 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
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.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.