COVID-19 Ag Rapid Test - India CDSCO Medical Device Registration

COVID-19 Ag Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000068_9c72700591e0bddb084d6fb85623b765_fb7e07c2ed418b9b3443804121466315. This device is marketed under the brand name PathKits Simple COVID-19 Ag Rapid Kit. The license holder is PATHKITS HEALTHCARE PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Sub Zonal Baddi.

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CDSCO Registered

Class Class C

COVID-19 Ag Rapid Test

UID: MFG/IVD/2021/000068_9c72700591e0bddb084d6fb85623b765_fb7e07c2ed418b9b3443804121466315

Brand Name

PathKits Simple COVID-19 Ag Rapid Kit

License Holder

PATHKITS HEALTHCARE PRIVATE LIMITED

Device Class

Class C

Approving Authority

Sub Zonal Baddi

Product Information

The Simple COVID-19 Ag Rapid Test is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal and nasopharyngeal (PathKits Simple COVID-19 Ag Rapid Kit) swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms. It is intended for the identification of infection with SARS-CoV-2, in the human body