CDSCO UID IMP/IVD/2020/000348_513f485c08084e4da96f1dea70c2e1c2_805f8e4136143ab0351fbee698b5da85

Novel Coronavirus Diagnostic kit

M/s. Elder Projects Limited·Device Class Class C·India CDSCO·Brand: 2019-nCoV
Registration details
UID
IMP/IVD/2020/000348_513f485c08084e4da96f1dea70c2e1c2_805f8e4136143ab0351fbee698b5da85
Device class
Class C
Brand name
2019-nCoV
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.
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About this record

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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