AFIAS Rota/Adeno - India CDSCO Medical Device Registration

AFIAS Rota/Adeno is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000365_b5428afc0eb3aa5f48a8a76d0d86b15b_29ab018b60dfc5110e7ff3c37e5e5bb0. 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/Adeno

UID: IMP/IVD/2021/000365_b5428afc0eb3aa5f48a8a76d0d86b15b_29ab018b60dfc5110e7ff3c37e5e5bb0

Brand Name

AFIAS ST2

License Holder

BODITECH MED INDIA PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

AFIAS Rota/Adeno is a fluorescence immunoassay ( AFIAS ST2) for the qualitative determination of both rotavirus and adenovirus in human feces. It is useful as an aid in management and monitoring of viral gastroenteritis. 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