SCoV-2 IgG ELISA Kit - India CDSCO Medical Device Registration

SCoV-2 IgG ELISA Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000672_7e1f78a2e96f060be848267dd33fb5bb_d360cce95af2dc19c711c01af541c464. This device is marketed under the brand name SCoV-2 DetectTM IgG ELISA. The license holder is SIRUS BIOCARE PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

SCoV-2 IgG ELISA Kit

UID: IMP/IVD/2020/000672_7e1f78a2e96f060be848267dd33fb5bb_d360cce95af2dc19c711c01af541c464

Brand Name

SCoV-2 DetectTM IgG ELISA

License Holder

SIRUS BIOCARE PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

The SCoV-2 Detect™ IgG ELISA is an in vitro diagnostic test for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum. The SCoV-2 Detect™ IgG ELISA is intended as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.