Pure Global
CDSCO UID MFG/IVD/2021/000085_dd829268caacf735852c337ca181f924_a83d2a6bba8555c7d0a806999dcc89de

One Step Hepatitis B Surface Antigen Test Device

M/s ASTAM DIAGNOSTICS PVT. LTD.·Device Class Class D·India CDSCO·Brand: Pratham
Registration details
UID
MFG/IVD/2021/000085_dd829268caacf735852c337ca181f924_a83d2a6bba8555c7d0a806999dcc89de
Device class
Class D
Brand name
Pratham
License holder
M/s ASTAM DIAGNOSTICS PVT. LTD.
Approving authority
CDSCO -North Zone, Ghaziabad
Product information
HBsAg Test is a lateral flow through immunochromatographic test for the qualitative detection of hepatitis B surface antigen (Pratham) in human serum/ plasma/whole blood.
Similar products (4)
Other products with the same name or brand
One Step Hepatitis B Surface Antigen Test Device
Brand: Nanz Comfort HIV-1 & HIV-2 Antibodies Test Device
NANZ MED SCIENCE PHARMA PRIVATE LIMITED
Class D
One Step Syphilis Antibodies to Treponema Pallidum Test Device
Brand: Pratham
M/s ASTAM DIAGNOSTICS PVT. LTD.
Class D
HCV antibody test
Brand: Pratham
M/s ASTAM DIAGNOSTICS PVT. LTD.
Class D
One Step HIV-1 & HIV-2 Antibodies Test Device
Brand: Pratham
M/s ASTAM DIAGNOSTICS PVT. LTD.
Class D
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 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
Troponin I test
Brand: Pratham ®
Class C
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

One Step Hepatitis B Surface Antigen Test Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000085_dd829268caacf735852c337ca181f924_a83d2a6bba8555c7d0a806999dcc89de. 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 D. 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.