SARS-CoV-2 Antigen Assay Kit (SARS-CoV-2 Antigen Assay Kit ) - India CDSCO Medical Device Registration

SARS-CoV-2 Antigen Assay Kit (SARS-CoV-2 Antigen Assay Kit ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000383_e720b6ce2dbeeb098a16c1c038566950_234f87a5305b8756aac47654d320b7a0. This device is marketed under the brand name Immunofluorescence. The license holder is BIODX HEALTHCARE, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

SARS-CoV-2 Antigen Assay Kit (SARS-CoV-2 Antigen Assay Kit )

UID: IMP/IVD/2020/000383_e720b6ce2dbeeb098a16c1c038566950_234f87a5305b8756aac47654d320b7a0

Brand Name

Immunofluorescence

License Holder

BIODX HEALTHCARE

Device Class

Class C

Approving Authority

CDSCO

Product Information

This kit is used for the qualitative detection of specific antigens to SARS-CoV-2 present in human Oropharyngeal swab, nasopharynx swab.

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