CDSCO UID MFG/IVD/2020/000150_dda12582ddbecd9fbac11c194f894f83_0cf3e06db79346a927b7faff14fc6107
Rapid Antigen Self Testing Kit for COVID-19
NeoDx Biotech Labs Pvt Ltd·Device Class Class C·India CDSCO
Registration details
- UID
- MFG/IVD/2020/000150_dda12582ddbecd9fbac11c194f894f83_0cf3e06db79346a927b7faff14fc6107
- Device class
- Class C
- License holder
- NeoDx Biotech Labs Pvt Ltd
- Approving authority
- Sub Zonal Bangalore
- Product information
- NeoCheck Rapid Antigen Self Test Kit is an In-vitro diagnostic immunochromatographic rapid antigen test kit for the qualitative detection of SARS-CoV-2 in symptomatic & asymptomatic individuals. This test is authorized for non-prescription home use, by any user (NA) in a private setting, to aid in the diagnosis of an active SARS-CoV-2 infection. The self-collected nasal swab specimens from individuals 18 years and above, can be used to perform the test. In case of individuals in the range 2 - 18 years, the test must be performed under adult supervision. Collecting the nasal swab sample, and conduct of the procedure is to be performed by the supervising adult
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About this record
Rapid Antigen Self Testing Kit for COVID-19 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000150_dda12582ddbecd9fbac11c194f894f83_0cf3e06db79346a927b7faff14fc6107. The license holder is NeoDx Biotech Labs Pvt Ltd, and it is classified as Device Class Class C. The approving authority is Sub Zonal Bangalore.
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