Novel Coronavirus IgG/IgM Rapid Test kit - India CDSCO Medical Device Registration

Novel Coronavirus IgG/IgM Rapid Test kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000170_f77d3e0fb85b1f22979815526a523c61_0ff0e6882fafec4159722f54af573f2c. This device is marketed under the brand name 2019-nCoV. The license holder is Gland Pharma Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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

Powered by Pure Global AI

CDSCO Registered

Class Class C

Novel Coronavirus IgG/IgM Rapid Test kit

UID: IMP/IVD/2020/000170_f77d3e0fb85b1f22979815526a523c61_0ff0e6882fafec4159722f54af573f2c

Brand Name

2019-nCoV

License Holder

Gland Pharma Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The product is a solid phase immunochromatographic assay for the rapid, qualitative/ semi-quantitative and differential detection of IgG and IgM antibodies to 2019-nCoV in human whole blood, serum or plasma

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Similar Products (10)

Other products with the same name or brand

Coronavirus

Brand: 2019-nCoV

Regulatory1

Real-Time OneStep RT-PCR based assay system for detection of COVID19(DiaPlexQ Novel Coronavirus Detection kit CV-IVD)

Brand: 2019-nCoV

Shree Venkatesh Medical Agencies

DiaPlexQTH Novel Coronavirus Detection Kit(DiaPlexQTH Novel Coronavirus Detection Kit)-The DiaPlexQ™ Novel Coronavirus Detection Kit is a real-time reverse transcriptase

Brand: 2019-nCoV

Bi-Biotech India Pvt Ltd

Novel Coronavirus Nucleic Acid Diagnostic Kit

Brand: 2019-nCoV

Mili Healthcare Private Limited

DiaPlexQ™ Novel Coronavirus Detection Kit

Brand: 2019-nCoV

HEALTH ARX TECHNOLOGIES PRIVATE LIMITED

Novel Coronavirus IgM/IgG Antibody Test Kit

Brand: 2019-nCoV

S A Diagnostics Private Limited

Novel Coronavirus RT-PCR Kit

Brand: 2019-nCoV

KDH BIOMEDICALS PVT LTD

Novel Coronavirus RT-PCR Detection Kit(Novel Coronavirus RT-PCR Detection Kit)

Brand: 2019-nCoV

VINCLAN TECHNOLOGIES PRIVATE LIMITED

Novel Coronavirus Diagnostic kit

Brand: 2019-nCoV

M/s. Elder Projects Limited

Novel Coronavirus Real Time Multiplex RT-PCR Kit(Novel Coronavirus Real Time Multiplex RT-PCR Kit)

Brand: 2019-nCoV

ADVY CHEMICAL PVT. LTD.

Other Products from Gland Pharma Limited

Products from the same license holder (6 products)

Bulk Syringes

Brand: EZ-Fill

Prefillable Glass barrel with Needle

Brand: Sterile

Novel Coronavirus RT- PCR Detection Kit

Brand: 2019-nCoV

Nucleic Acid Extraction and Purification Kit

Brand: 2019-nCoV

Nucleic Acid Extraction and Purification Kit

Brand: 2019-nCoV

Preservation buffer

Brand: 2019-nCoV