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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 IgG/IgM Rapid Test (For Reader)

Manufactured by Acro Biotech Inc, United States - www.acrobiotech.com 

Device identification number
1677
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-03-14 09:42:40 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
0 AU
Calibration
not evaluated
Crossreactivity
evaluated
Fp
5.6 AU
Fn
5 AU
Precision
evaluated
Accuracy
94.9 % ( (IgG/IgM))
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
94.4 %

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