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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/2020/000077_e920296fa1e52bbb4411daca8cb851e8_8958daf238837750573d26ef6b875522. This device is marketed under the brand name Quidel Triage® Total 3 Control 1. The license holder is M/s Parekh Integrated Services Pvt. Ltd., 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/2020/000077_e920296fa1e52bbb4411daca8cb851e8_8958daf238837750573d26ef6b875522

Brand Name

Quidel Triage® Total 3 Control 1

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Quidel Triage Troponin I Test is a fluorescence immunoassay to be used with the Quidel Triage Meters for the quantitative determination of troponin I in EDTA anticoagulated whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (Quidel Triage® Total 3 Control 1)

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