Biomerica COVID-19 IgG/IgM Rapid Strip Test (1507B)
Manufactured by Biomerica, Inc., United States - biomerica.com/index.asp
Device identification number
1603
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Strip
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
data available upon request
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
0 AU
Calibration
evaluated
Crossreactivity
evaluated
Fp
10 AU
Fn
2 AU
Precision
evaluated
Accuracy
96.6 %
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
96.9 %
Type of antigen
nucleoprotein
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