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

COVID-19 IgG/IgM Rapid Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000217_5f378472567b019bd118ddf9feadf2cb_2cace11eb6b880881c628dcd0b3ef2a3. This device is marketed under the brand name Elabscience. The license holder is Krishgen Biosystems, 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/IgM Rapid Test Kit

UID: IMP/IVD/2020/000217_5f378472567b019bd118ddf9feadf2cb_2cace11eb6b880881c628dcd0b3ef2a3

Brand Name

Elabscience

License Holder

Krishgen Biosystems

Device Class

Class C

Approving Authority

CDSCO

Product Information

COVID-19 IgG/IgM Rapid Test (Elabscience) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to COVID-19 in human whole blood, serum or plasma as an aid in the diagnosis of primary and secondary COVID-19 infections.