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CDSCO UID MFG/IVD/2019/000026_f2442570483f00061f1fbc5ae9474219_68598bbae02a29eee027e3a987aa1be8

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

Nucleus Diagnosys LLP·Device Class Class D·India CDSCO·Brand: HIV 1&2
Registration details
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.
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About this record

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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