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Multiple cardiac marker IVD, kit, fluorescent immunoassay - India CDSCO Medical Device Registration

Multiple cardiac marker IVD, kit, fluorescent immunoassay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000077_afab7778696a60cf9107648f8548d9f2_0224f9eb8878c5cecc0020332ae8d2f4. 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
Multiple cardiac marker IVD, kit, fluorescent immunoassay
UID: IMP/IVD/2020/000077_afab7778696a60cf9107648f8548d9f2_0224f9eb8878c5cecc0020332ae8d2f4

Brand Name

Quidel Triage® Total 3 Control 1

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Quidel Triage Cardiac Panel is a fluorescence immunoassay to be used with the Quidel Triage Meters for the quantitative determination of creatine kinase MB (Quidel Triage® Total 3 Control 1), myoglobin and troponin I in EDTA anticoagulated whole blood or 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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