CDSCO UID IMP/IVD/2022/000478_b969fe29fd9370553b4bd36285272add_c0944b4669d32f1231033e7587f47519
Coronavirus
Regulatory1·Device Class Class C·India CDSCO·Brand: 2019-nCoV
Registration details
- UID
- IMP/IVD/2022/000478_b969fe29fd9370553b4bd36285272add_c0944b4669d32f1231033e7587f47519
- Device class
- Class C
- Brand name
- 2019-nCoV
- License holder
- Regulatory1
- Approving authority
- CDSCO
- Product information
- Antigentest-(2019-nCoV)-This kit for self-testing is used for in vitro qualitative determination of SARS-CoV-2 antigen in human anterior nasal swab samples. It can be used for rapid investigation of SARS-CoV-2 antigen from individuals suspected of COVID-19 within the first seven days of the onset of symptoms and the individuals without symptoms. Children and young people under the age of 18 should be supported by an adult.
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About this record
Coronavirus is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000478_b969fe29fd9370553b4bd36285272add_c0944b4669d32f1231033e7587f47519. This device is marketed under the brand name 2019-nCoV. The license holder is Regulatory1, and it is classified as Device Class Class C. The approving authority is CDSCO.
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