Troponin-I Test Kit - India CDSCO Medical Device Registration

Troponin-I Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000068_7d22a057db8a2edc17eafe632d5b9f3e_17eb02f2de2a863be453f8b5209500f1. This device is marketed under the brand name PathKits Simple COVID-19 Ag Rapid Kit. The license holder is PATHKITS HEALTHCARE PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Sub Zonal Baddi.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class C

Troponin-I Test Kit

UID: MFG/IVD/2021/000068_7d22a057db8a2edc17eafe632d5b9f3e_17eb02f2de2a863be453f8b5209500f1

Brand Name

PathKits Simple COVID-19 Ag Rapid Kit

License Holder

PATHKITS HEALTHCARE PRIVATE LIMITED

Device Class

Class C

Approving Authority

Sub Zonal Baddi

Product Information

The Troponin I Rapid Test Device (PathKits Simple COVID-19 Ag Rapid Kit) is a rapid visual immunoassay for the qualitative presumptive detection of cardiac Troponin- I in human whole blood, serum, or plasma specimens. This kit is intended to be used as an aid in the diagnosis of myocardial infarction (PathKits Simple COVID-19 Ag Rapid Kit) A rapid visual Immunoassay for the qualitative presumptive detection of cardiac Troponin I in human whole blood, serum, or plasma specimens