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BNP, CK-MB, Troponin I, D-dimer and Myoglobin cardiac marker IVD, control - India CDSCO Medical Device Registration

BNP, CK-MB, Troponin I, D-dimer and Myoglobin cardiac marker IVD, control is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000472_8d0295dbe8a89c3f1b5a977b4133759b_4afcf56a3e79a3e07ffae41a8feac4de. 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
BNP, CK-MB, Troponin I, D-dimer and Myoglobin cardiac marker IVD, control
UID: IMP/IVD/2023/000472_8d0295dbe8a89c3f1b5a977b4133759b_4afcf56a3e79a3e07ffae41a8feac4de

Brand Name

Quidel Triage® Total 5 Control 2

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Quidel Triage Total 5 Controls are assayed materials to be used with the Quidel Triage Cardiac Panel, Quidel Triage Profiler SOB Panel, Quidel Triage BNP Test, Quidel Triage D Dimer Test, and Quidel Triage Meters to assist the laboratory in monitoring test performance

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