2019-nCoV(COVID-19) IgG&IgM Rapid Test Kit
Manufactured by Neo Nostics (Suzhou) Bioingeneering Co. LTD - http://www.neo-nostics.com/en/About_us/
Device identification number
1022
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
03/15/2021 09:14
Comments
I cannot find the CE-IVD label but it is an ISO certified producer (AMP). Seems to be IVD from the pic (ES)
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Subclass
N.A.
LOD
Not found
Calibration
Not found
Crossreactivity
Not found
Fp
Not found
Fn
Not found
Precision
Not found
Accuracy
Not found
Reproducibility
Not found
Robustness
Not found
Clinical Sensitivity
Not found
Clinical Specificity
Not found
Notes
Rapid diagnostic test cassette
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