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_d10104d2781ac40d3f0f84e62674eba0_af09c55dd8d7e43463b9b68cac33bd4d. 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_d10104d2781ac40d3f0f84e62674eba0_af09c55dd8d7e43463b9b68cac33bd4d

Brand Name

Gargle based

License Holder

Meril Diagnostics Pvt. Ltd.

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

It is a qualitative, In-vitro diagnostic immuno-chromatography assay for the detection of Hepatitis B surface antigen (Gargle based) a marker for Hepatitis B infection in human serum, plasma, capillary and/or venous whole blood. The test is intended for use by the trained competent person and healthcare professionals as an aid to the diagnosis in either laboratory or point of-care settings