Novel Coronavirus Diagnostic kit - India CDSCO Medical Device Registration
Novel Coronavirus Diagnostic kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000348_513f485c08084e4da96f1dea70c2e1c2_805f8e4136143ab0351fbee698b5da85. This device is marketed under the brand name 2019-nCoV. The license holder is M/s. Elder Projects Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
2019-nCoV
License Holder
M/s. Elder Projects LimitedDevice Class
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 and feces from suspected pneumonia cases with novel coronavirus infection, patients with suspected clusters of novel coronavirus infection, and other patients requiring diagnosis or differential diagnosis of novel coronavirus infection.
Coronavirus
Brand: 2019-nCoV
Regulatory1
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