Novel Coronavirus Nucleic Acid Diagnostic Kit
- UID
- IMP/IVD/2020/000238_f371b3b59f6401fb9c65e8b9dd6a4fee_3a681611beec032f71d4fe941976bb36
- Device class
- Class C
- Brand name
- 2019-nCoV
- License holder
- Inbios India
- 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
Novel Coronavirus Nucleic Acid Diagnostic Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000238_f371b3b59f6401fb9c65e8b9dd6a4fee_3a681611beec032f71d4fe941976bb36. This device is marketed under the brand name 2019-nCoV. The license holder is Inbios India, and it is classified as Device Class Class C. The approving authority is CDSCO.
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