Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019-nCoV IgG/IgM Rapid Test Cassette

Manufactured by Hangzhou AllTest Biotech Co., Ltd - http://www.alltests.com.cn/ 

Device identification number
208
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
N.A.
Target
Antibody
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
03/18/2021 09:03
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
N.A.
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Subclass
N.A.
LOD
Not Reported
Calibration
Not Reported
Crossreactivity
Not Reported
Fp
Not Reported
Fn
Not Reported
Precision
Not Reported
Accuracy
Not Reported
Reproducibility
Not Reported
Robustness
Not Reported
Clinical Sensitivity
Not Reported
Clinical Specificity
Not Reported
Type of antigen
Notes
Rapid diagnostic test Not found

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