CDSCO UID MFG/IVD/2020/000021_86449a39b53a38feedab2981f67cb631_4d26a873e6ecad7b4d798ba2e5ee86ed
Human Influenza Detection Kit
Mylab Discovery S0lutions Pvt. Ltd·Device Class Class C·India CDSCO·Brand: Multigene-Multiplex Single tube format
Registration details
- UID
- MFG/IVD/2020/000021_86449a39b53a38feedab2981f67cb631_4d26a873e6ecad7b4d798ba2e5ee86ed
- Device class
- Class C
- Brand name
- Multigene-Multiplex Single tube format
- License holder
- Mylab Discovery S0lutions Pvt. Ltd
- Approving authority
- Central Drug Standards Control Organization, West Zone
- Product information
- Human Influenza Detection Kit is a multiplex real-time RT-PCR assay intended for the simultaneous in vitro qualitative detection and differentiation of influenza A, influenza B and influenza A subtype (A(Multigene-Multiplex Single tube format)pdm09 and H3N2) viral nucleic acid in upper or lower respiratory specimens (Multigene-Multiplex Single tube format) collected from individuals suspected of respiratory viral infection. Human Influenza Detection Kit is not intended to detect the influenza C virus. Influenza A and influenza B viral RNA are generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of active infection but do not rule out bacterial infection or co-infection with other pathogens not detected by the test. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of the disease. Negative results do not preclude influenza A and/or B infection and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information
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About this record
Human Influenza Detection Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000021_86449a39b53a38feedab2981f67cb631_4d26a873e6ecad7b4d798ba2e5ee86ed. This device is marketed under the brand name Multigene-Multiplex Single tube format. The license holder is Mylab Discovery S0lutions Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.
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