CDSCO UID IMP/IVD/2020/000382_81b956e9a084ea77fb3432bf6137fb87_c4ccfdb7b7072f3d4a2f754a24d16f84

Novel Coronavirus RT-PCR Kit

KDH BIOMEDICALS PVT LTD·Device Class Class C·India CDSCO·Brand: 2019-nCoV

Registration details

UID: IMP/IVD/2020/000382_81b956e9a084ea77fb3432bf6137fb87_c4ccfdb7b7072f3d4a2f754a24d16f84
Device class: Class C
Brand name: 2019-nCoV
License holder: KDH BIOMEDICALS PVT LTD
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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About this record

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.

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