Novel Coronavirus antibody test kit (Novel Coronavirus Antibody Test) - India CDSCO Medical Device Registration
Novel Coronavirus antibody test kit (Novel Coronavirus Antibody Test) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000381_d7f8b566c30c0445fa62095f44449f32_4c9f52987480a2deee78a136babb6bf3. This device is marketed under the brand name 2019- nCoV. The license holder is M/s. Elder Projects 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.
Brand Name
2019- nCoV
License Holder
M/s. Elder Projects LimitedDevice Class
Approving Authority
CDSCO
Product Information
This kit is used for the qualitative detection of Novel Coronavirus (2019- nCoV) antibodies in Human Serum, Plasma and Venous whole blood samples in vitro. It is only used as a supplementary indicator for suspected cases of novel coronavirus nucleic acid testing or in conjunction with nucleic acid detection in the diagnosis of suspected cases, and it cannot be used as a basis for the diagnosis and conclusion of Pneumonia caused by Novel Coronavirus, and not suitable for general population screening. It is only for Medical Institutions.
