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CDSCO UID MFG/IVD/2020/000043_1e242e469324d2013d8ef42e8c4c6fb5_f80d2b2399894d5dda399be469d90d02

Anti-SARS Coronavirus COVID-19 IgG ELISA for the qualitative detection of IgG antibodies to SARS CoV-2 in human serum/plasma

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_1e242e469324d2013d8ef42e8c4c6fb5_f80d2b2399894d5dda399be469d90d02
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
The Qualisa Covid IgG ELISA assay is intended for the qualitative in-vitro detection of novel coronavirus infected cases. The cases are screened based on the detection of human antibodies (QUALISA COVID 19 IgG ELISA) specifically against new coronavirus (QUALISA COVID 19 IgG ELISA) in serum/plasma samples from COVID-19 suspected/infected person. The Kit is for laboratory professional use or health-care professionals
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About this record

Anti-SARS Coronavirus COVID-19 IgG ELISA for the qualitative detection of IgG antibodies to SARS CoV-2 in human serum/plasma is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000043_1e242e469324d2013d8ef42e8c4c6fb5_f80d2b2399894d5dda399be469d90d02. 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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