GLINE-2019-nCoV IgM/IgG
Manufactured by SHENZHEN YHLO BIOTECH Co. Ltd., China - http://www.szyhlo.com
Device identification number
1082
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://pdf.medicalexpo.com/pdf/shenzhen-yhlo-biotech-co-ltd/reagent-sars-cov-2-poct/107786-227353.html
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
Clinical Sensitivity
88.55 % IgM
Clinical Sensitivity
94.58 % IgG
Clinical Sensitivity
96.39 %
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements