MALARIA PF/PV ANTIGEN TEST - India CDSCO Medical Device Registration

MALARIA PF/PV ANTIGEN TEST is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000021_9d88702d71b1bf853376ddadb5ae713a_affec343fa5a243f3c677f217322452d. This device is marketed under the brand name Multigene-Multiplex Single tube format. The license holder is Mylab Discovery S0lutions Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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 PF/PV ANTIGEN TEST

UID: MFG/IVD/2020/000021_9d88702d71b1bf853376ddadb5ae713a_affec343fa5a243f3c677f217322452d

Brand Name

Multigene-Multiplex Single tube format

License Holder

Mylab Discovery S0lutions Pvt. Ltd

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

Malaria Pf/Pv Test is intended for the qualitative detection of Plasmodium falciparum (Multigene-Multiplex Single tube format) specific Histidine Rich Protein 2 (Multigene-Multiplex Single tube format) and Plasmodium vivax specific Plasmodium lactate dehydrogenase (Multigene-Multiplex Single tube format) for screening and diagnosis of malaria from human blood (Multigene-Multiplex Single tube format). Also, differential diagnosis between Pf HRP-II (Multigene-Multiplex Single tube format) and pLDH (Multigene-Multiplex Single tube format) specific to P. vivax. Malaria Pf/Pv Test Kit is intended to be used by trained healthcare or other healthcare workers as well as for self-testing

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

CMV Quantitative PCR Kit

Brand: Multigene-Multiplex Single tube format

Mylab Discovery S0lutions Pvt. Ltd

MALARIA PF/PV ANTIGEN TEST - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

CMV Quantitative PCR Kit

Phenylalanine Detection Test

Malaria Pf Antigen Test

G6PD Detection Test

CRP FIA Test

Detection of Novel Coronavirus 2019-nCoV/SARS-CoV-2 from clinical samples

Rubella Detection Kit

COVID-19 S Plus Rapid PCR Kit

Human Influenza Detection Kit

Sickle Cell Rapid Test

CMV Quantitative PCR Kit

Phenylalanine Detection Test

BULK PRE COATED NCM SHEETS & ANTIGEN EXTRACTION BUFFER

Malaria Pf Antigen Test

HIV 1/2 Ab Test

HCV Ab Test

G6PD Detection Test

Syphilis Antibody Test

CRP FIA Test

Detection of Novel Coronavirus 2019-nCoV/SARS-CoV-2 from clinical samples