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D-DIMER CALIBRATOR - India CDSCO Medical Device Registration

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.

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 CALIBRATOR
UID: MFG/IVD/2020/000138_b27fcd9c0436be5215d4949774144138_4aabe1048e882f2fb9789c29953c3e04

Brand Name

Concepta D-DIMER Control

Device Class

Class C

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

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