Pure Global

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

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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database
Powered by Pure Global AI
CDSCO Registered
Class Class D
Anti-SARS Coronavirus COVID-19 IgG ELISA for the qualitative detection of IgG antibodies to SARS CoV-2 in human serum/plasma
UID: MFG/IVD/2020/000043_1e242e469324d2013d8ef42e8c4c6fb5_f80d2b2399894d5dda399be469d90d02

Brand Name

QUALISA COVID 19 IgG ELISA

Device Class

Class D

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

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Similar Products (1)
Other products with the same name or brand

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

Brand: QUALISA COVID 19 IgG ELISA

ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED

Class D
Other Products from ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Products from the same license holder (10 products)

Rapid Test for Malaria Pv/Pf

Brand: CA 15-3

Class C

Rapid Test for Malaria PAN/Pf

Brand: CA 15-3

Class C

Rapid Test for Malaria PAN

Brand: CA 15-3

Class C

Rapid Test for Syphilis (SYPHICHECK )

Brand: CA 15-3

Class C

Enzyme Linked Immunosorbent Assay for the Quantitative Determination of Ovarian Cancer Antigen in Human Serum

Brand: CA 15-3

Class C

Enzyme Linked Immunosorbent Assay for the Quantitative Determination of Alpha Feto Protein in Human Serum

Brand: CA 15-3

Class C

Fluorescence Immunoassay for Quantitative detection of Prostate Specific Antigen in Human Serum/Plasma

Brand: CA 15-3

Class C

Chemiluminescence Assay for the Quantitative Determination of Ovarian Cancer Antigen in Human Serum

Brand: CA 15-3

Class C

Enzyme Linked Immunosorbent Assay for the Quantitative Determination of Breast Cancer Antigen in Human Serum

Brand: CA 15-3

Class C

Fluorescence Immunoassay for Quantitative detection of Cardiac Troponin I in Human Serum/Plasma

Brand: CA 15-3

Class C