D-DIMER CALIBRATOR
- UID
- MFG/IVD/2020/000138_b27fcd9c0436be5215d4949774144138_4aabe1048e882f2fb9789c29953c3e04
- 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
- Material for the preparation of calibration curves for the quantitative determination, in human plasma, of cross-linked derivatives of fibrin decomposition that contain D - Dimer, using Concepta and other types of reagents on automated analysers, or any other type of discrete analyser, or automated biochemical analysers
D-DIMER CALIBRATOR is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000138_b27fcd9c0436be5215d4949774144138_4aabe1048e882f2fb9789c29953c3e04. 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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