CDSCO UID IMP/IVD/2020/000292_d4a33fb21f8d105b255d6e8d02199528_f97a853f7836c29a20eb6e08bb76dad4

One Step Test for Novel Coronavirus IgM/IgG antibody

Inbios India·Device Class Class C·India CDSCO·Brand: 2019-nCoV

Registration details

UID: IMP/IVD/2020/000292_d4a33fb21f8d105b255d6e8d02199528_f97a853f7836c29a20eb6e08bb76dad4
Device class: Class C
Brand name: 2019-nCoV
License holder: Inbios India
Approving authority: CDSCO
Product information: One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (2019-nCoV) is intended for the qualitative detection of 2019-Novel Coronavirus IgM and IgG antibody in serum, plasma, fingertip blood or whole blood samples of pneumonitis patients or suspected cases.

Similar products (10)

Other products with the same name or brand

Real-Time OneStep RT-PCR based assay system for detection of COVID19(DiaPlexQ Novel Coronavirus Detection kit CV-IVD)

Brand: 2019-nCoV

Shree Venkatesh Medical Agencies

Class C

DiaPlexQTH Novel Coronavirus Detection Kit(DiaPlexQTH Novel Coronavirus Detection Kit)-The DiaPlexQ™ Novel Coronavirus Detection Kit is a real-time reverse transcriptase

Brand: 2019-nCoV

Bi-Biotech India Pvt Ltd

Class C

Novel Coronavirus Nucleic Acid Diagnostic Kit

Brand: 2019-nCoV

Mili Healthcare Private Limited

Class C

DiaPlexQ™ Novel Coronavirus Detection Kit

Brand: 2019-nCoV

HEALTH ARX TECHNOLOGIES PRIVATE LIMITED

Class C

Novel Coronavirus IgM/IgG Antibody Test Kit

Brand: 2019-nCoV

S A Diagnostics Private Limited

Class C

Novel Coronavirus RT-PCR Kit

Brand: 2019-nCoV

KDH BIOMEDICALS PVT LTD

Class C

Novel Coronavirus RT-PCR Detection Kit(Novel Coronavirus RT-PCR Detection Kit)

Brand: 2019-nCoV

VINCLAN TECHNOLOGIES PRIVATE LIMITED

Class B

Novel Coronavirus Diagnostic kit

Brand: 2019-nCoV

M/s. Elder Projects Limited

Class C

Novel Coronavirus Real Time Multiplex RT-PCR Kit(Novel Coronavirus Real Time Multiplex RT-PCR Kit)

Brand: 2019-nCoV

ADVY CHEMICAL PVT. LTD.

Class C

Other products from Inbios India

Products from the same license holder (9 products)

Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test

Brand: Cellex

Class C

Novel Coronavirus Nucleic Acid Diagnostic Kit

About this record

One Step Test for Novel Coronavirus IgM/IgG antibody is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000292_d4a33fb21f8d105b255d6e8d02199528_f97a853f7836c29a20eb6e08bb76dad4. This device is marketed under the brand name 2019-nCoV. The license holder is Inbios India, 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.