COVID -19 IgG ELISA KIT - India CDSCO Medical Device Registration

COVID -19 IgG ELISA KIT is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000285_7ac6a321a61efe9b303a5b6e07b0966a_7c608a610fd8ca7f52d208ff2e198622. This device is marketed under the brand name COVID -19 IgG ELISA KIT. The license holder is Omega DX (Asia) 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

COVID -19 IgG ELISA KIT

UID: IMP/MD/2018/000285_7ac6a321a61efe9b303a5b6e07b0966a_7c608a610fd8ca7f52d208ff2e198622

Brand Name

COVID -19 IgG ELISA KIT

License Holder

Omega DX (Asia) Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

COVID - 19 IgG ELISA KIT IS A SEMI QUANTATIVE ELISA KIT FOR DETECTION OF IgG ANTIBODIES TO SARS -CoV-2 IN HUMAN SERUM OR PLASMA AS AN AID TO DIAGNOSIS OF ACTIVE COVID 19 INFECTION IN SYMPTOMATIC AMD ASYMPTOMATIC INDIVIDUALS. THE TEST SHOULD BE CONSIDERED IN CONJUNCATION WITH OTHER TEST RESULTS & CLINICAL INFORMATION. DETECTION OF ANTIBODIES MAY INDICATE IMMUNITY OR ATTENUATION TO SUBSEQUENT RE - INFECTION.