Quik Pac II COVID-19 IgG & IgM Test
Manufactured by Tianjin New Bay Bioresearch C, China - not found
Device identification number
1631
CE Marking
×No
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
Crossreactivity
Influenza A, Influenza B, Adenovirus, HBsAg, Syphilis, H.Pylori, HIV I, HIV II, HCV, TB
Fp
10.6 %
Fn
2.3 %
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