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/2022/000064_e920296fa1e52bbb4411daca8cb851e8_cb239d14d79c1f9993ffb93de5e81d03. This device is marketed under the brand name Quidel Triage® TOX Drug Screen, 94600 Control 2. The license holder is Quidel Diagnostics India 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/2022/000064_e920296fa1e52bbb4411daca8cb851e8_cb239d14d79c1f9993ffb93de5e81d03

Brand Name

Quidel Triage® TOX Drug Screen, 94600 Control 2

License Holder

Quidel Diagnostics India Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Quidel TriageTrue High Sensitivity Troponin I Test is a fluorescence immunoassay to be used with the Triage® MeterPro for the quantitative determination of troponin I in EDTA anticoagulated whole blood and plasma specimens. The test is to be used as an aid in the diagnosis of myocardial infarction (Quidel Triage® TOX Drug Screen, 94600 Control 2)

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Troponin I IVD, kit, fluorescent immunoassay

Brand: Quidel Triage® Total 5 Control 2

M/s. Ortho Clinical Diagnostics India Private Limited

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

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Troponin I IVD, kit, fluorescent immunoassay

Troponin I IVD, kit, fluorescent immunoassay

Troponin I IVD, Control

Troponin I IVD, kit, fluorescent immunoassay

BNP, CK-MB, Troponin I, D-dimer and Myoglobin cardiac marker IVD, control

BNP, CK-MB, Troponin I, D-dimer and Myoglobin cardiac marker IVD, control

BNP and Troponin I cardiac marker IVD, kit, fluorescent immunoassay

Troponin I, BNP and D-dimer cardiac marker IVD, kit, fluorescent immunoassay

BNP, CK-MB and Troponin I cardiac marker IVD, control

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay

Fluorescent Immunoassay Analyzer

Troponin I IVD, Control

Troponin I IVD, kit, fluorescent immunoassay

BNP, CK-MB, Troponin I, D-dimer and Myoglobin cardiac marker IVD, control

BNP, CK-MB, Troponin I, D-dimer and Myoglobin cardiac marker IVD, control

BNP and Troponin I cardiac marker IVD, kit, fluorescent immunoassay

Troponin I, BNP and D-dimer cardiac marker IVD, kit, fluorescent immunoassay

BNP, CK-MB and Troponin I cardiac marker IVD, control

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay