One Step Test for Novel Coronavirus IgM/IgG antibody - India CDSCO Medical Device Registration

One Step Test for Novel Coronavirus IgM/IgG antibody is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000292_d4a33fb21f8d105b255d6e8d02199528_f97a853f7836c29a20eb6e08bb76dad4. This device is marketed under the brand name 2019-nCoV. The license holder is Inbios India, 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

CDSCO Registered

Class Class C

One Step Test for Novel Coronavirus IgM/IgG antibody

UID: IMP/IVD/2020/000292_d4a33fb21f8d105b255d6e8d02199528_f97a853f7836c29a20eb6e08bb76dad4

Brand Name

2019-nCoV

License Holder

Inbios India

Device Class

Class C

Approving Authority

CDSCO

Product Information

One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (2019-nCoV) is intended for the qualitative detection of 2019-Novel Coronavirus IgM and IgG antibody in serum, plasma, fingertip blood or whole blood samples of pneumonitis patients or suspected cases.