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Enzyme Linked Immunosorbent Assay for detection of Hepatitis B Surface Antigen in human serum or plasma - India CDSCO Medical Device Registration

Enzyme Linked Immunosorbent Assay for detection of Hepatitis B Surface Antigen in human serum or plasma is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000113_f2315450fea3360eac3f46fb300630ee_724875a0c02c4c54d25fdc8becee15f4. This device is marketed under the brand name Device. The license holder is QUALPRO DIAGNOSTICS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class D. The approving authority is Sub Zonal Goa.

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CDSCO Registered
Class Class D
Enzyme Linked Immunosorbent Assay for detection of Hepatitis B Surface Antigen in human serum or plasma
UID: MFG/IVD/2021/000113_f2315450fea3360eac3f46fb300630ee_724875a0c02c4c54d25fdc8becee15f4

Brand Name

Device

Device Class

Class D

Approving Authority

Sub Zonal Goa

Product Information

Qualisa HBsAg is intended to be used for the detection of Hepatitis B surface antigen in human serum / plasma

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