COVID-19 IgG/IgM Rapid Test - India CDSCO Medical Device Registration

COVID-19 IgG/IgM Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000029_ad6f3b4c7102b5f913b0d3003e12aac5_08fa445dd50143c0827afc12368ece75. This device is marketed under the brand name Gargle based. The license holder is Meril Diagnostics Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class D

COVID-19 IgG/IgM Rapid Test

UID: MFG/MD/2018/000029_ad6f3b4c7102b5f913b0d3003e12aac5_08fa445dd50143c0827afc12368ece75

Brand Name

Gargle based

License Holder

Meril Diagnostics Pvt. Ltd.

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The Diagnostic Kit Colloidal Gold for IgG/IgM Antibody to SARSCOV- 2 is a rapid immunoassay for the qualitative detection of antibodies (Gargle based) to SARS-COV-2 virus in Whole Blood /Serum / Plasma