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Troponin I IVD, Control - India CDSCO Medical Device Registration

Troponin I IVD, Control is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000472_f0c01a1399b0015172f359b3c6b52248_2b4b1643e879877e3551769e578de328. This device is marketed under the brand name Quidel Triage® Total 5 Control 2. The license holder is M/s. Ortho Clinical Diagnostics India Private Limited, 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.

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CDSCO Registered
Class Class C
Troponin I IVD, Control
UID: IMP/IVD/2023/000472_f0c01a1399b0015172f359b3c6b52248_2b4b1643e879877e3551769e578de328

Brand Name

Quidel Triage® Total 5 Control 2

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Quidel TriageTrue High Sensitivity Troponin I Controls are assayed materialsto be used with the Quidel TriageTrue High Sensitivity Troponin I Test, and Quidel Triage®MeterPro to assist the end user in monitoring test performance

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