Pure Global

Diagnostics test reagent/ kits for Troponin I - India CDSCO Medical Device Registration

Diagnostics test reagent/ kits for Troponin I is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2019/000026_c4f71382fe710c124dcb323e34938521_4999b9cccff82a6191c5c39cc9ee2387. This device is marketed under the brand name TRA. The license holder is Nucleus Diagnosys LLP, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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
Powered by Pure Global AI
CDSCO Registered
Class Class C
Diagnostics test reagent/ kits for Troponin I
UID: MFG/IVD/2019/000026_c4f71382fe710c124dcb323e34938521_4999b9cccff82a6191c5c39cc9ee2387

Brand Name

TRA

License Holder

Nucleus Diagnosys LLP

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Use detection of Cardiac Troponin I in human whole blood, serum or plasma

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Other Products from Nucleus Diagnosys LLP
Products from the same license holder (10 products)

Diagnostics test reagent/ kits for RF, ASO and CRP Control

Class C

Covid-19 Rapid Antigen Test-COVID-19 Antigen Test is a rapid and convenient immunochromatographic assay for the qualitative detection of COVID-19 antigen from nasopharyngeal/nasal swab obtained from patient with signs and symptoms of respiratory infection. This test is for administration by healthcare workers and labs only, as an aid to early diagnosis of SARS-CoV-2 infection in patient with clinical symptoms of SARS-CoV-2 infection. It provides only an initial screening test result. This product is strictly for medical professional use only and not intended for personal use. The result of this test should not be the sole basis for the diagnosis and the test results should be confirmed by Real-Time Reverse Transcriptase

Brand: HIV 1&2

Class D

Diagnostic tests/Reagents/kits for monitoring Phencyclidine drug levels used for therapy or abuse.

Class C

Diagnostic tests/Reagents/kits for monitoring Barbiturates drug levels used for therapy or abuse.

Class C

Diagnostic tests/Reagents/kits for monitoring Methaqualone drug levels used for therapy or abuse.

Class C

Diagnostic tests/Reagents/kits for monitoring Tricycilic Antidepressants drug levels used for therapy or abuse.

Class C

Diagnostic tests/Reagents/kits for monitoring Propoxyphene drug levels used for therapy or abuse.

Class C

Diagnostic tests/Reagents/kits for monitoring Methamphetamine drug levels used for therapy or abuse

Class C

Diagnostics Test for Syphilis Rapid Test

Class D

Diagnostics test reagent/Kit for Hepatitis B Virus Surface Antigen

Brand: HIV 1&2

Class D