D-DIMER Test Kit
- UID
- MFG/IVD/2020/000138_80a548620a44c6e83206b941c4619092_f5db9b55b98b68c3ea6beb3e0b8ccd86
- Device class
- Class C
- Brand name
- Concepta D-DIMER Control
- License holder
- BIOSYSTEMS DIAGNOSTICS PRIVATE LIMITED
- 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)
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.
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