Diagnostic Kit for IgM/IgG Antibody to Coronavirus - India CDSCO Medical Device Registration

Diagnostic Kit for IgM/IgG Antibody to Coronavirus is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000308_57ce9ce0b764ee7140ef0baaad24c4e5_d4409af969bcd15f3c0fab1102f361e1. This device is marketed under the brand name SARS-CoV-2. The license holder is Core Diagnostics Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Diagnostic Kit for IgM/IgG Antibody to Coronavirus

UID: IMP/IVD/2020/000308_57ce9ce0b764ee7140ef0baaad24c4e5_d4409af969bcd15f3c0fab1102f361e1

Brand Name

SARS-CoV-2

License Holder

Core Diagnostics Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

This product is used for in vitro qualitative detection of Coronavirus (SARS-CoV-2) IgM/IgG antibody in human serum, plasma and venous whole blood samples. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Not for the screening of the general population. For professional use only.