AFIAS NORO - India CDSCO Medical Device Registration

AFIAS NORO is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000365_d25f9bf946b5fbd33e09658ef0453551_4c6ae4eb17425eabb56ff82f67b2a2b7. 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 NORO

UID: IMP/IVD/2021/000365_d25f9bf946b5fbd33e09658ef0453551_4c6ae4eb17425eabb56ff82f67b2a2b7

Brand Name

AFIAS ST2

License Holder

BODITECH MED INDIA PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

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

Class C

COVID-19 Ag

Brand: AFIAS ST2

BODITECH MED INDIA PRIVATE LIMITED

Class C

Brand: AFIAS Infliximab

Class B