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Novel Coronavirus Nucleic Acid Diagnostic Kit - India CDSCO Medical Device Registration

Novel Coronavirus Nucleic Acid Diagnostic Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000657_91a1a7fad6cfe77bdef59d922f0325b9_658c178f46f0d17cdc5e7a46e3c42f94. This device is marketed under the brand name 2019-nCoV. The license holder is Mili Healthcare Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Novel Coronavirus Nucleic Acid Diagnostic Kit
UID: IMP/IVD/2020/000657_91a1a7fad6cfe77bdef59d922f0325b9_658c178f46f0d17cdc5e7a46e3c42f94

Brand Name

2019-nCoV

Device Class

Class C

Approving Authority

CDSCO

Product Information

Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit (2019-nCoV) is used for qualitative detection of the ORF1ab and N genes of novel coronavirus (2019-nCoV) in nasopharyngeal swab, oropharyngeal swab, alveolar lavage fluid, sputum, serum, whole blood, feces from suspected pneumonia cases with novel coronavirus infection, in patients with suspected clusters of novel coronavirus infection, and other patients requiring diagnosis or differential diagnosis of novel coronavirus infection.

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