Rapid Double Antigen Screening test for the detection of IgM / IgG / IgA antibodies to COVID-19 in human serum/ plasma/ whole blood - India CDSCO Medical Device Registration
Rapid Double Antigen Screening test for the detection of IgM / IgG / IgA antibodies to COVID-19 in human serum/ plasma/ whole blood is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000118_a0e89c58ca1ac049c988279c59567837_a7ed45a4dd5f2c0690f5799dd3ed86f8. This device is marketed under the brand name Device. The license holder is ORCHID BIOMEDICAL SYSTEMS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class D. The approving authority is Sub Zonal Goa.
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Brand Name
Device
Device Class
Approving Authority
Sub Zonal Goa
Product Information
Coviscreen is an invitro, rapid, self performing, qualitative, Double Antigen sandwich immunoassay for the simultaneous detection of Total antibodies (Device) to SARS-CoV-2 virus in serum, plasma and whole blood. It is to be used for screening or to aid in the diagnosis of COVID-19 disease and exposure to the virus. Double Antigen Sandwich assays are also known to detect the Antigen specific IgA isotype antibodies and contribute to detect the seroconversion in patients samples earlier as compared to the other tests as detection of total antibodies (Device) is possible
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