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One Step rapid test for detection of Hepatitis B Surface Antigen - India CDSCO Medical Device Registration

One Step rapid test for detection of Hepatitis B Surface Antigen is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000005_6e153fc5716753f89209f77875a1adac_e210b90b320ebd9a56bbf7b293350ad5. This device is marketed under the brand name Standard Q HIV 1/2 Ab 4-line ,Ultra HIV 1/2 Ab 4-line. The license holder is SD Biosensor Healthcare Pvt. Ltd, and it is classified as Device Class Class D. The approving authority is Sub Zonal Baddi.

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CDSCO Registered
Class Class D
One Step rapid test for detection of Hepatitis B Surface Antigen
UID: MFG/MD/2018/000005_6e153fc5716753f89209f77875a1adac_e210b90b320ebd9a56bbf7b293350ad5

Brand Name

Standard Q HIV 1/2 Ab 4-line ,Ultra HIV 1/2 Ab 4-line

Device Class

Class D

Approving Authority

Sub Zonal Baddi

Product Information

It is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B surface antigen (Standard Q HIV 1/2 Ab 4-line ,Ultra HIV 1/2 Ab 4-line) present in serum or plasma

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