CDSCO UID MFG/IVD/2019/000026_f2442570483f00061f1fbc5ae9474219_68598bbae02a29eee027e3a987aa1be8Covid-19 Rapid Antigen Test-COVID-19 Antigen Test is a rapid and convenient immunochromatographic assay for the qualitative detection of COVID-19 antigen from nasopharyngeal/nasal swab obtained from patient with signs and symptoms of respiratory infection. This test is for administration by healthcare workers and labs only, as an aid to early diagnosis of SARS-CoV-2 infection in patient with clinical symptoms of SARS-CoV-2 infection. It provides only an initial screening test result. This product is strictly for medical professional use only and not intended for personal use. The result of this test should not be the sole basis for the diagnosis and the test results should be confirmed by Real-Time Reverse Transcriptase
- UID
- MFG/IVD/2019/000026_f2442570483f00061f1fbc5ae9474219_68598bbae02a29eee027e3a987aa1be8
- Device class
- Class D
- Brand name
- HIV 1&2
- License holder
- Nucleus Diagnosys LLP
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- PCR Diagnostic kit. The test is intended for professional and laboratory use.
Covid-19 Rapid Antigen Test-COVID-19 Antigen Test is a rapid and convenient immunochromatographic assay for the qualitative detection of COVID-19 antigen from nasopharyngeal/nasal swab obtained from patient with signs and symptoms of respiratory infection. This test is for administration by healthcare workers and labs only, as an aid to early diagnosis of SARS-CoV-2 infection in patient with clinical symptoms of SARS-CoV-2 infection. It provides only an initial screening test result. This product is strictly for medical professional use only and not intended for personal use. The result of this test should not be the sole basis for the diagnosis and the test results should be confirmed by Real-Time Reverse Transcriptase is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2019/000026_f2442570483f00061f1fbc5ae9474219_68598bbae02a29eee027e3a987aa1be8. This device is marketed under the brand name HIV 1&2. The license holder is Nucleus Diagnosys LLP, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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