One Step Test for HBsAg - India CDSCO Medical Device Registration

One Step Test for HBsAg is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000029_8614dd2d7c953609a9d12561a3446705_e28770221fd45cc366c461c594cc83dd. This device is marketed under the brand name Gargle based. The license holder is Meril Diagnostics Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class D

One Step Test for HBsAg

UID: MFG/MD/2018/000029_8614dd2d7c953609a9d12561a3446705_e28770221fd45cc366c461c594cc83dd

Brand Name

Gargle based

License Holder

Meril Diagnostics Pvt. Ltd.

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The One Step Test for HBsAg (Gargle based) is used in further manufacturing of One Step Test for HBsAg (Gargle based). It is a rapid, qualitative, sand-witch immunoassay for the detection of Hepatitis B surface antigen (Gargle based) a marker for Hepatitis B infection in human serum or plasma by trained competent person