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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Brand Name
HCV
License Holder
Recombigen Laboratories Pvt LtdDevice Class
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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