One Step Test for HBsAg
- UID
- MFG/MD/2018/000029_d10104d2781ac40d3f0f84e62674eba0_af09c55dd8d7e43463b9b68cac33bd4d
- Device class
- Class D
- Brand name
- Gargle based
- License holder
- Meril Diagnostics Pvt. Ltd.
- 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
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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