AFIAS ROTA - India CDSCO Medical Device Registration

AFIAS ROTA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000365_c03bba1154da4474a465851bf8644a4a_e6a5d4cc7433968af284f550043cf974. This device is marketed under the brand name AFIAS ST2. The license holder is BODITECH MED INDIA PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

AFIAS ROTA

UID: IMP/IVD/2021/000365_c03bba1154da4474a465851bf8644a4a_e6a5d4cc7433968af284f550043cf974

Brand Name

AFIAS ST2

License Holder

BODITECH MED INDIA PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

AFIAS ROTA is a fluorescence immunoassay ( AFIAS ST2) for the qualitative determination of Rotavirus in human feces. It is useful as an aid in screening of Rotavirus infection. For in vitro diagnostic use only

Class C

COVID-19 Ag

Brand: AFIAS ST2

BODITECH MED INDIA PRIVATE LIMITED

Class C

Brand: AFIAS ST2

Class C