OFM GmbH
Manufactured by OFM Medical, Germany - www.OFM-Medical.de
Device identification number
2202
CE Marking
×No
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Test zur Eigenanwendung – nach § 11MPG befristete Sonderzulassung durch BfArM, Aktenzeichen 5640-S-140/21 -> CE Certification is under progress -> until then special confirmation from BfArM
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Time
15 minutes
LOD
65 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
1.86 % ((4 of 214))
Precision
Evaluated
Accuracy
100 %
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
96 %
Clinical Specificity
100 %
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