HBsAg FIA Test - India CDSCO Medical Device Registration

HBsAg FIA Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000021_73ecbfd2ddfa4116ad96e80db42ec4a1_39fcb3a0a2c63e436b9262ef03d08f12. 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

HBsAg FIA Test

UID: MFG/IVD/2020/000021_73ecbfd2ddfa4116ad96e80db42ec4a1_39fcb3a0a2c63e436b9262ef03d08f12

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

HBsAg FIA Test is a fluorescent immunoassay for the detection of Hepatitis B surface antigen (PathoCatchTM) present in human specimen. The detection of the hepatitis antigen is useful in the diagnosis of hepatitis B. This test is an in-vitro professional use and used for initial screening test