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Novel Coronavirus RT-PCR Kit - India CDSCO Medical Device Registration

Novel Coronavirus RT-PCR Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000382_81b956e9a084ea77fb3432bf6137fb87_c4ccfdb7b7072f3d4a2f754a24d16f84. This device is marketed under the brand name 2019-nCoV. The license holder is KDH BIOMEDICALS PVT LTD, 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.

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CDSCO Registered
Class Class C
Novel Coronavirus RT-PCR Kit
UID: IMP/IVD/2020/000382_81b956e9a084ea77fb3432bf6137fb87_c4ccfdb7b7072f3d4a2f754a24d16f84

Brand Name

2019-nCoV

Device Class

Class C

Approving Authority

CDSCO

Product Information

Novel Coronavirus (2019-nCoV) RT-PCR Kit is a polymerase chain reaction IVD test to detect RNA of 2019-nCoV in samples like upper respiratory tract samples (2019-nCoV), lower respiratory tract samples (2019-nCoV), conjunctival swabs, stool specimens, anticoagulant and serum,2019-nCOV IgG/IgM Rapid Test(2019-nCoV)-The 2019-nCOV IgG/IgM Rapid Test is based on rapid immunochromatographic test. It is used for the detection of 2019 Novel Coronavirus (2019-nCoV) IgG and IgM antibody in human whole blood/serum/plasma, offering a diagnostic reference for COVID-19

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