Troponin I Rapid Diagnostic Test Kit - India CDSCO Medical Device Registration

Troponin I Rapid Diagnostic Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000164_9f896bf66e9892624d39d89d1f93464f_02ce8064e5cf81753b469b379ea2cf21. This device is marketed under the brand name AccuTest Troponin I Rapid Diagnostic Test Kit. The license holder is Accurex Biomedical Pvt Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class C

Troponin I Rapid Diagnostic Test Kit

UID: MFG/IVD/2022/000164_9f896bf66e9892624d39d89d1f93464f_02ce8064e5cf81753b469b379ea2cf21

Brand Name

AccuTest Troponin I Rapid Diagnostic Test Kit

License Holder

Accurex Biomedical Pvt Ltd

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

AccuTest Troponin I is intended to be used for qualitative detection of human cardiac Troponin I in serum/plasma/whole blood as an aid in diagnosis of myocardial infarction (AccuTest Troponin I Rapid Diagnostic Test Kit)