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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

iFlash-SARS-CoV-2 IgM

Manufactured by SHENZHEN YHLO BIOTECH CO., Ltd, China - http://www.szyhlo.com 

Device identification number
1080
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-03-14 09:42:40 CET
Comments
https://pdf.medicalexpo.com/pdf/shenzhen-yhlo-biotech-co-ltd/clia-iflash-3000/107786-227346.html
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
30 minutes
Detection Principle
Chemiluminescence
LOD
10 U/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
80.8 % (7 days)
Clinical Sensitivity
92.3 % (8-14 days)

Related Scientific Literature

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