COVID-19 FIA Test Kit - India CDSCO Medical Device Registration

COVID-19 FIA Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000021_058cefaba3489018ddf803b921a9143b_349630eb26d1220f58140bbaa2f91960. This device is marketed under the brand name PathoCatchTM. The license holder is Mylab Discovery S0lutions Pvt. Ltd, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class D

COVID-19 FIA Test Kit

UID: MFG/IVD/2020/000021_058cefaba3489018ddf803b921a9143b_349630eb26d1220f58140bbaa2f91960

Brand Name

PathoCatchTM

License Holder

Mylab Discovery S0lutions Pvt. Ltd

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

COVID-19 FIA Test Kit is a lateral flow immunofluorescent sandwich assay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. The COVID-19 FIA Test Kit should be used with FIA analyzers– MyBox FIA analyzer or Gazelle™ FIA analyzer. It is intended for professional use, only for an initial screening test