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D-DIMER Test Kit - India CDSCO Medical Device Registration

D-DIMER Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000138_80a548620a44c6e83206b941c4619092_f5db9b55b98b68c3ea6beb3e0b8ccd86. This device is marketed under the brand name Concepta D-DIMER Control. The license holder is BIOSYSTEMS DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Central Drug Standard Control Organisation, South Zone.

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.

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CDSCO Registered
Class Class C
D-DIMER Test Kit
UID: MFG/IVD/2020/000138_80a548620a44c6e83206b941c4619092_f5db9b55b98b68c3ea6beb3e0b8ccd86

Brand Name

Concepta D-DIMER Control

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

D Dimer Test kit is intended for In-vitro quantitative determination of D-Dimer in human plasma. D-dimer is a fibrin degradation product, a small protein fragment present in blood after fibrinolysis degrades a blood clot. D- dimer is normally undetectable in the blood and is synthesized only after a clot has formed and is in the process of being broken down. D-dimer levels rise when a significant formation and breakdown of blood clots occurs. D- dimer is useful in diagnosis of deep vein thrombosis (Concepta D-DIMER Control), pulmonary embolism (Concepta D-DIMER Control), and disseminated intravascular coagulation (Concepta D-DIMER Control)

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