2019-nCoV IgM Control - India CDSCO Medical Device Registration
2019-nCoV IgM Control is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000088_2143b24417934fcb671cb9c7417d6985_46a24c9206bb758018ae9e7b04761064. This device is marketed under the brand name YHLO. The license holder is M/s. CPC Diagnostics Pvt Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
YHLO
License Holder
M/s. CPC Diagnostics Pvt LtdDevice Class
Approving Authority
CDSCO
Product Information
2019-nCoV IgM Control is used to check the reliability of 2019-nCoV IgM assay. The performance of 2019-nCoV IgM Control has not been evaluated for other assays or instruments,iFlash-2019-nCoV NAb(YHLO)-The iFlash-2019-nCoV Neutralization Antibody (YHLO) assay is a paramagnetic particle chemiluminescent immunoassay (YHLO) for the quantitative determination of 2019-nCoV neutralization antibody in human serum and plasma using the automated iFlash Immunoassay Analyzer. It is intended to be used for evaluation of neutralizing antibodies in patients who had recovered from COVID-19 or monitor neutralization antibodies in people who had COVID-19 vaccination. iFlash-2019-nCoV Neutralization Antibody (YHLO) assay is not intended to be used for diagnose or to exclude 2019-nCoV or SARS-COV-2 infection.
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