Respiratory Pathogen Detection Kit
- UID
- IMP/IVD/2022/000273_72bb11aad945d3bbc997d190a9f13930_eb7f9c618724d2cbd92b25c344919ea7
- Device class
- Class C
- Brand name
- RespiFinder® 2SMART
- License holder
- ADT India Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- The RespiFinder® 2SMART (RespiFinder® 2SMART) Kit is a qualitative multiplex PCR test to detect and differentiate within 2.5 hours 16 RNA viruses, 2 DNA viruses as well as 4 bacteria, all of which can cause respiratory tract infections in humans: adenovirus, bocavirus, coronavirus NL63/HKU1, coronavirus OC43, coronavirus 229E, hMPV, influenza A, influenza B, influenza A H1N1pdm09, parainfluenza 1, parainfluenza 2, parainfluenza 3, parainfluenza 4, rhinovirus/enterovirus, RSV-A, RSV-B, Bordetella pertussis, Chlamydophila pneumoniae, Legionella pneumophila and Mycoplasma pneumoniae. The RespiFinder® 2SMART kit aids in the diagnosis of respiratory tract infection when used in conjunction with other clinical and laboratory findings. Negative results do not necessarily indicate absence of viral or bacterial respiratory tract infection; negative results should not be used as the sole basis for diagnosis, therapy, or other treatment decisions. Positive results do not exclude co-infection with other pathogens. The pathogen(RespiFinder® 2SMART) detected may not be the definite cause of disease. The RespiFinder® 2SMART is for use with LightCycler® 480 (RespiFinder® 2SMART) and Rotor-Gene Q (RespiFinder® 2SMART).
Respiratory Pathogen Detection Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000273_72bb11aad945d3bbc997d190a9f13930_eb7f9c618724d2cbd92b25c344919ea7. This device is marketed under the brand name RespiFinder® 2SMART. The license holder is ADT India Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.
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