COVID-19 Ag - India CDSCO Medical Device Registration

COVID-19 Ag is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000365_2cbd6e3cdbc08bdab44f7eaa52b71bbc_323f34d346b674714999d5c35a031f36. 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

COVID-19 Ag

UID: IMP/IVD/2021/000365_2cbd6e3cdbc08bdab44f7eaa52b71bbc_323f34d346b674714999d5c35a031f36

Brand Name

AFIAS ST2

License Holder

BODITECH MED INDIA PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

AFIAS COVID-19 Ag is a fluorescence Immunoassay ( AFIAS ST2) for the qualitative detection of novel corona virus ( AFIAS ST2) in human nasopharyngeal swab. It is useful as an aid in the screening of early mild, asymptomatic, or acute patients for identification of 'Novel Coronavirus' infection

Class C

CRP

Brand: AFIAS ST2

BODITECH MED INDIA PRIVATE LIMITED

Class C

Brand: AFIAS ST2

Class C