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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_0a1ac4418eff6fda31d130f82350cc52. 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_0a1ac4418eff6fda31d130f82350cc52

Brand Name

Quidel Triage® Total 5 Control 2

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Quidel TriageTrue High Sensitivity Troponin I Test is a fluorescenceimmunoassay to be used with the Triage® MeterPro for the quantitative determination of troponinI in EDTA anticoagulated whole blood and plasma specimens. The test is to be used as an aid in thediagnosis of myocardial infarction (Quidel Triage® Total 5 Control 2)

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