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CDSCO UID IMP/IVD/2023/000472_e920296fa1e52bbb4411daca8cb851e8_734b667e92c3eb1f35958b0c177b6e63

Troponin I IVD, kit, fluorescent immunoassay

M/s. Ortho Clinical Diagnostics India Private Limited·Device Class Class C·India CDSCO·Brand: Quidel Triage® Total 5 Control 2
Registration details
UID
IMP/IVD/2023/000472_e920296fa1e52bbb4411daca8cb851e8_734b667e92c3eb1f35958b0c177b6e63
Device class
Class C
Brand name
Quidel Triage® Total 5 Control 2
License holder
M/s. Ortho Clinical Diagnostics India Private Limited
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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About this record

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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