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Rapid Antigen Self Testing Kit for COVID-19 - India CDSCO Medical Device Registration

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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CDSCO Registered
Class Class C
Rapid Antigen Self Testing Kit for COVID-19
UID: MFG/IVD/2020/000150_dda12582ddbecd9fbac11c194f894f83_0cf3e06db79346a927b7faff14fc6107

Device Class

Class C

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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