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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Chemtrue® Novel Coronavirus(2019-nCoV) IgM Antibody Diagnostic Kit (Colloidal Gold)

Manufactured by Shanghai Chemtron Biotech Co. Ltd., China - http://www.chemtronbio.com/ 

Device identification number
357
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antibody, IgM
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
product code:8035C
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
89.61 % IgM
Clinical Specificity
100 % IgM
Type of antigen
Other

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