Cardiac Troponin I (AuraFIA Cardiac Troponin I ) - India CDSCO Medical Device Registration

Cardiac Troponin I (AuraFIA Cardiac Troponin I ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000248_b07acc2abae6d228d47e584e31cf8d00_c4ef87fbba2503a8fac517551963d1f4. This device is marketed under the brand name Time-resolved Fluorescence Immunochromatographic Assay. The license holder is INDO-MIM TEC 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

Cardiac Troponin I (AuraFIA Cardiac Troponin I )

UID: IMP/IVD/2022/000248_b07acc2abae6d228d47e584e31cf8d00_c4ef87fbba2503a8fac517551963d1f4

Brand Name

Time-resolved Fluorescence Immunochromatographic Assay

License Holder

INDO-MIM TEC PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

This kit is suitable for in vitro quantitative detection of the concentration of Troponin I (Time-resolved Fluorescence Immunochromatographic Assay) in human serum, plasma and whole blood. This product is used for testing in medical and health institutions for the auxiliary diagnosis of myocardial injury caused by acute myocardial infarction and other diseases

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