Dr. PCR™ Di20K COVID-19 Detection kit
Manufactured by OPTOLANE Technologies Inc., South Korea - www.optolane.com/
Device identification number
1954
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cartridge
Target type
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Digital Real-time PCR
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Method
Digital-PCR
Measurement
Qualitative
Time
60 minutes
LOD
2.5 cpm (RdRp and E gene)
Clinical Sensitivity
100 %
Clinical Specificity
100 %
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