Pure Global
CDSCO UID MFG/IVD/2021/000085_25c7d9aebb9c785077e83c6b15ab6a81_12e75ec4a0bbcf0840fc50978fe43406

Troponin I test

M/s ASTAM DIAGNOSTICS PVT. LTD.·Device Class Class C·India CDSCO·Brand: Pratham ®
Registration details
UID
MFG/IVD/2021/000085_25c7d9aebb9c785077e83c6b15ab6a81_12e75ec4a0bbcf0840fc50978fe43406
Device class
Class C
Brand name
Pratham ®
License holder
M/s ASTAM DIAGNOSTICS PVT. LTD.
Approving authority
CDSCO -North Zone, Ghaziabad
Product information
Troponin-I is an in vitro diagnostic test based on immunochromatographic assay. It is designed for qualitative determination of Cardiac Troponin-I (Pratham ®) in human serum / plasma/ Whole blood as an aid in the diagnosis of acute myocardial infarction (Pratham ®).
Similar products (3)
Other products with the same name or brand
One Step Dengue Antigen NS1 Test
Brand: Pratham ®
M/s ASTAM DIAGNOSTICS PVT. LTD.
Class C
One Step Dengue NS1 Antigen and Antibodies Test
Brand: Pratham ®
M/s ASTAM DIAGNOSTICS PVT. LTD.
Class C
One Step Malaria Antigen P.f/ P.v Test Device
Brand: Pratham ®
M/s ASTAM DIAGNOSTICS PVT. LTD.
Class C
Other products from M/s ASTAM DIAGNOSTICS PVT. LTD.
Products from the same license holder (10 products)
Blood Pressure Monitoring Devices
Brand: Pratham® Digital Thermometer
Class B
Digital Thermometer
Brand: Pratham® Digital Thermometer
Class B
One Step Hepatitis B Surface Antigen Test Device
Brand: Pratham
Class D
One Step Dengue Antigen NS1 Test
Brand: Pratham ®
Class C
One Step Syphilis Antibodies to Treponema Pallidum Test Device
Brand: Pratham
Class D
One Step Dengue NS1 Antigen and Antibodies Test
Brand: Pratham ®
Class C
HCV antibody test
Brand: Pratham
Class D
One Step Malaria Antigen P.f/ P.v Test Device
Brand: Pratham ®
Class C
One Step HIV-1 & HIV-2 Antibodies Test Device
Brand: Pratham
Class D
H. Pylori antibody test
Brand: human Chorionic Gonadotropin
Class B
About this record

Troponin I test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000085_25c7d9aebb9c785077e83c6b15ab6a81_12e75ec4a0bbcf0840fc50978fe43406. This device is marketed under the brand name Pratham ®. The license holder is M/s ASTAM DIAGNOSTICS PVT. LTD., and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.

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.