SARS-CoV-2 Nucleic Acid Detection Kit - India CDSCO Medical Device Registration

SARS-CoV-2 Nucleic Acid Detection Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000383_145c6973baea1c6f53b3548a1731e3a3_e50a9a6aa54cf3aef48d89dea1975eee. 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 Nucleic Acid Detection Kit

UID: IMP/IVD/2020/000383_145c6973baea1c6f53b3548a1731e3a3_e50a9a6aa54cf3aef48d89dea1975eee

Brand Name

Immunofluorescence

License Holder

BIODX HEALTHCARE

Device Class

Class C

Approving Authority

CDSCO

Product Information

This kit is used inqualitative detection in vitro of SARS-CoV-2 RNA in sputum, throat swab, alveolar lavage fluids specimens from suspected COVID-19 cases, suspected clustered cases, other cases requiring SARS-CoV-2 diagnosis or differential diagnosis

DJ Fang

MedTech Regulatory Expert

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