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CDSCO UID IMP/IVD/2022/000088_2143b24417934fcb671cb9c7417d6985_46a24c9206bb758018ae9e7b04761064

2019-nCoV IgM Control

M/s. CPC Diagnostics Pvt Ltd·Device Class Class C·India CDSCO·Brand: YHLO
Registration details
UID
IMP/IVD/2022/000088_2143b24417934fcb671cb9c7417d6985_46a24c9206bb758018ae9e7b04761064
Device class
Class C
Brand name
YHLO
License holder
M/s. CPC Diagnostics Pvt Ltd
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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About this record

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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