COVID-19 Antigen Rapid Card Test - India CDSCO Medical Device Registration

COVID-19 Antigen Rapid Card Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000024_f31e9e7fafc4e9972219171afa612227_8cde2d708567bf282b52560f862f9ba9. This device is marketed under the brand name TRURAPID® Dengue NS-1 Ag Test. The license holder is KILPEST INDIA LIMITED, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class C

COVID-19 Antigen Rapid Card Test

UID: MFG/IVD/2020/000024_f31e9e7fafc4e9972219171afa612227_8cde2d708567bf282b52560f862f9ba9

Brand Name

TRURAPID® Dengue NS-1 Ag Test

License Holder

KILPEST INDIA LIMITED

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

TRURAPID® COVID-19 Ag Test is a lateral flow immunoassay, intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2, from Nasopharyngeal swabs of COVID-19 suspected individuals by healthcare providers. TRURAPID® COVID-19 Ag Test does not differentiate between SARS-CoV and SARS-CoV-2.