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 IMP/IVD/2019/000307_ad6f3b4c7102b5f913b0d3003e12aac5_5bbde3a8297555f708ed461ed2a2aaea. This device is marketed under the brand name RecombiLISA. The license holder is Athenese-Dx Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

COVID-19 IgG/IgM Rapid Test

UID: IMP/IVD/2019/000307_ad6f3b4c7102b5f913b0d3003e12aac5_5bbde3a8297555f708ed461ed2a2aaea

Brand Name

RecombiLISA

License Holder

Athenese-Dx Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The OnSite COVID-19 IgG/IgM Rapid Test is a lateral flow immunoassay for the detection of anti-SARS-CoV-2 IgG and IgM antibodies in human serum, plasma or whole blood. It is intended to be used by healthcare professionals as an aid in the diagnosis of infection with SARS-CoV-2 coronavirus, which causes COVID-19 disease.

Class B

HAV IgG/IgM Rapid Test

Brand: RecombiLISA

Athenese-Dx Private Limited

Class B

Brand: TRUSTline

Class D