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Troponin I IVD, kit, fluorescent immunoassay - India CDSCO Medical Device Registration

Troponin I IVD, kit, fluorescent immunoassay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000472_e920296fa1e52bbb4411daca8cb851e8_734b667e92c3eb1f35958b0c177b6e63. 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.

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CDSCO Registered
Class Class C
Troponin I IVD, kit, fluorescent immunoassay
UID: IMP/IVD/2023/000472_e920296fa1e52bbb4411daca8cb851e8_734b667e92c3eb1f35958b0c177b6e63

Brand Name

Quidel Triage® Total 5 Control 2

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Quidel Triage Troponin I Test is a fluorescence immunoassay to be used withthe Quidel Triage Meters for the quantitative determination of troponin I in EDTA anticoagulatedwhole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardialinfarction (Quidel Triage® Total 5 Control 2)

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