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CDSCO UID IMP/IVD/2020/000657_91a1a7fad6cfe77bdef59d922f0325b9_658c178f46f0d17cdc5e7a46e3c42f94

Novel Coronavirus Nucleic Acid Diagnostic Kit

Mili Healthcare Private Limited·Device Class Class C·India CDSCO·Brand: 2019-nCoV
Registration details
UID
IMP/IVD/2020/000657_91a1a7fad6cfe77bdef59d922f0325b9_658c178f46f0d17cdc5e7a46e3c42f94
Device class
Class C
Brand name
2019-nCoV
License holder
Mili Healthcare Private Limited
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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About this record

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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