One Step Malaria P.f/P.v antigen Rapid test - India CDSCO Medical Device Registration

One Step Malaria P.f/P.v antigen Rapid test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000005_dc3ece622dcafe5bbc3525f3ccac1e98_8bd2df9ac0fb5651793287b2f162a921. 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

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

UID: MFG/MD/2018/000005_dc3ece622dcafe5bbc3525f3ccac1e98_8bd2df9ac0fb5651793287b2f162a921

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 an immunochromatographic assay for the differential detection between plasmodium falciparum Histidine-Rich Protein-II (STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test) and pLDH (STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test) specific to Plasmodium vivax in human whole blood

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

One Step Malaria P.f/P.v antigen Rapid test - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Dengue virus Antigen Test Kits

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

Malaria Antigen test kits

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 COVID-19 Antigen Test

One Step COVID-19 Antigen Test

One Step COVID-19 Antigen Test