Pure Global
CDSCO UID MFG/IVD/2020/000043_a0e89c58ca1ac049c988279c59567837_60f7c7c0b43e15f4a161b0cec1ab1053

Rapid Double Antigen Screening test for the detection of IgM / IgG / IgA antibodies to COVID-19 in human serum/ plasma/ whole blood

ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED·Device Class Class D·India CDSCO·Brand: QUALISA COVID 19 IgG ELISA
Registration details
UID
MFG/IVD/2020/000043_a0e89c58ca1ac049c988279c59567837_60f7c7c0b43e15f4a161b0cec1ab1053
Device class
Class D
Brand name
QUALISA COVID 19 IgG ELISA
License holder
ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
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 (QUALISA COVID 19 IgG ELISA) 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 (QUALISA COVID 19 IgG ELISA) is possible.
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About this record

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/2020/000043_a0e89c58ca1ac049c988279c59567837_60f7c7c0b43e15f4a161b0cec1ab1053. This device is marketed under the brand name QUALISA COVID 19 IgG ELISA. The license holder is ZEPHYR BIOMEDICALS 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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