Malaria Antigen test kits - India CDSCO Medical Device Registration

Malaria Antigen test kits is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000005_b690689fc6cadbc60cb59b529a337474_db6b778405f40bb15a310f6a8dd4bdd1. This device is marketed under the brand name STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test. The license holder is SD Biosensor Healthcare Pvt. Ltd, 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

Malaria Antigen test kits

UID: MFG/MD/2018/000005_b690689fc6cadbc60cb59b529a337474_db6b778405f40bb15a310f6a8dd4bdd1

Brand Name

STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test

License Holder

SD Biosensor Healthcare Pvt. Ltd

Device Class

Class C

Approving Authority

Sub Zonal Baddi

Product Information

It is a rapid and membrane based immmunochromatography for the qualitative detection of Plasmodium falciparum (STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test) specific Histidine Rich Protein 2 (STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test) in human whole blood specimen. This test is in vitro professional diagnostic use and intended as an aid to diagnosis of the infection in patient with suspected malaria before treatment is administered. It provides only an initial screening test. Therefore, any reactive specimen with this test should be confirmed with alternative testing method such as microscopic examination of thin blood smear and clinical findings

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Dengue virus Antigen Test Kits

Brand: STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test

SD Biosensor Healthcare Pvt. Ltd

Malaria Antigen test kits - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Dengue virus Antigen Test Kits

One Step Malaria P.f/P.v antigen Rapid test

One Step COVID-19 Antigen Test

One Step COVID-19 Antigen Test

One Step COVID-19 Antigen Test

Troponin test kits

COVID-19 Antigen Self Test Kit

One Step Malaria Antigen P.f Test

One Step Dengue NS1 antigen test

Standard Q COVID-19 IgM/IgG DUO

Ultra Malaria Pf/Pan Ag

Ultra HIV 1/2 Ab

Ultra HCV Ab

Ultra Malaria P.f/P.v Ag

Ultra Malaria P.f Ag

One Step HIV 1/2 Antibody Test

Dengue virus Antigen Test Kits

One Step Malaria P.f/P.v antigen Rapid test

One Step COVID-19 Antigen Test

One Step COVID-19 Antigen Test