SARS-CoV-2 IgM IgG Antibody Assay Kit - India CDSCO Medical Device Registration

SARS-CoV-2 IgM IgG Antibody Assay Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000383_404728f8ee3d1bced90b3fced7b8ba26_2ffb2111993f631321bf183a0dbe94fb. This device is marketed under the brand name Immunofluorescence. The license holder is BIODX HEALTHCARE, and it is classified as Device Class Class C. The approving authority is CDSCO.

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 C

SARS-CoV-2 IgM IgG Antibody Assay Kit

UID: IMP/IVD/2020/000383_404728f8ee3d1bced90b3fced7b8ba26_2ffb2111993f631321bf183a0dbe94fb

Brand Name

Immunofluorescence

License Holder

BIODX HEALTHCARE

Device Class

Class C

Approving Authority

CDSCO

Product Information

qualitative detection of specific IgM antibodies and IgG antibodies against novel coronavirus (Immunofluorescence) in human specimens (Immunofluorescence)

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Similar Products (10)

Other products with the same name or brand

SARS-CoV-2 Antigen Assay Kit (SARS-CoV-2 Antigen Assay Kit )

Brand: Immunofluorescence

BIODX HEALTHCARE

NT-proBNP Assay (NT-proBNP Assay )

Brand: Immunofluorescence

BIODX HEALTHCARE

SARS-CoV-2 IgM/IgG Antibody Assay Kit (SARS-CoV-2 IgM/IgG Antibody Assay Kit )

Brand: Immunofluorescence

BIODX HEALTHCARE

Interleukin-6 Assay (Interleukin-6 Assay )

Brand: Immunofluorescence

BIODX HEALTHCARE

Troponin T/CK-MB/Myoglobin Assay (Troponin T/CK-MB/Myoglobin Assay )-Troponin T/CK-MB/Myoglobin Assay is used for the quantitative in vitro detection of troponin T , creatine kinase isoenzyme and myoglobin in human serum, plasma or whole blood samples.,cTnI Assay (cTnI Assay )

Brand: Immunofluorescence

BIODX HEALTHCARE

PCT Assay (PCT Assay )

Brand: Immunofluorescence

BIODX HEALTHCARE

C-Reactive Protein Assay (C-Reactive Protein Assay )

Brand: Immunofluorescence

BIODX HEALTHCARE

Nucleic Acid Extraction Kit

Brand: Immunofluorescence

BIODX HEALTHCARE

D-Dimer Assay (D-Dimer Assay )

Brand: Immunofluorescence

BIODX HEALTHCARE

SARS-CoV-2 Nucleic Acid Detection Kit

Brand: Immunofluorescence

BIODX HEALTHCARE

Other Products from BIODX HEALTHCARE

Products from the same license holder (10 products)

Blood Culture Positive Sample Pretreatment Kit

Brand: Blood Culture Positive Sample Pretreatment Kit

SARS-CoV-2 Antigen Assay Kit (SARS-CoV-2 Antigen Assay Kit )

Brand: Immunofluorescence

Substrate

Brand: Blood Culture Positive Sample Pretreatment Kit

NT-proBNP Assay (NT-proBNP Assay )

Brand: Immunofluorescence

Mold Sample Pretreatment Kit

Brand: Blood Culture Positive Sample Pretreatment Kit

SARS-CoV-2 IgM/IgG Antibody Assay Kit (SARS-CoV-2 IgM/IgG Antibody Assay Kit )

Brand: Immunofluorescence

Interleukin-6 Assay (Interleukin-6 Assay )

Brand: Immunofluorescence

T3 Assay (T3 Assay )

Brand: Blood Culture Positive Sample Pretreatment Kit

TSH Assay (TSH Assay )

Brand: Blood Culture Positive Sample Pretreatment Kit

25-hydroxyvitamin D (25-hydroxyvitamin D )

Brand: Blood Culture Positive Sample Pretreatment Kit