CDSCO UID MFG/IVD/2020/000130_62321ebb6bdf0b10635026041d2a303f_6992628a8a332de9ac2d6393992b7250
Rapid test for detection of SARS-CoV-2 Antigen in human nasopharyngeal swab specimens (COVIRAT )
VIOLA DIAGNOSTIC SYSTEMS - A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED,·Device Class Class C·India CDSCO·Brand: Paracheck Pf Device
Registration details
- UID
- MFG/IVD/2020/000130_62321ebb6bdf0b10635026041d2a303f_6992628a8a332de9ac2d6393992b7250
- Device class
- Class C
- Brand name
- Paracheck Pf Device
- Approving authority
- CDSCO -North Zone, Ghaziabad
- Product information
- Covirat is an invitro, rapid, qualitative immunoassay for the detection of nucleocapsid protein antigens expressed by the SARS-CoV-2 virus present in human nasopharyngeal swab specimens. It is to be used for screening or to aid in the diagnosis of COVID-19 disease. This rapid antigen detection test takes 15-30 minutes for producing a positive or negative test result. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Presumptive positive or negative result may need to be further confirmed with a molecular test.
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About this record
Rapid test for detection of SARS-CoV-2 Antigen in human nasopharyngeal swab specimens (COVIRAT ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000130_62321ebb6bdf0b10635026041d2a303f_6992628a8a332de9ac2d6393992b7250. This device is marketed under the brand name Paracheck Pf Device. The license holder is VIOLA DIAGNOSTIC SYSTEMS - A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED,, and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.
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