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Human Immunodeficiency Virus Test Kit - India CDSCO Medical Device Registration

Human Immunodeficiency Virus Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000082_e290e415f522f823e9f16f7136828877_5d0ec91e275373469cd24c62e154934d. This device is marketed under the brand name HCV. The license holder is Recombigen Laboratories Pvt Ltd, and it is classified as Device Class Class D. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered
Class Class D
Human Immunodeficiency Virus Test Kit
UID: MFG/IVD/2023/000082_e290e415f522f823e9f16f7136828877_5d0ec91e275373469cd24c62e154934d

Brand Name

HCV

Device Class

Class D

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

One Step Human Immunode๏€ciency Virus 1/2 (HCV) Antibody Test is a rapid and convenient immunochromato -graphic assay used for the qualitative detection of antibodies against HIV type 1 and type 2 in human serum, plasma or blood sample. It is intended for professional use as an aid in diagnosis of HIV infections. This assay provides only a preliminary result. Clinical expertise and professional judgement should be sought to further evaluate the result of the test

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