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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

LoopDeetect COVID 19 IC

Manufactured by LoopDeeScience, France - www.loopdeescience.com 

Device identification number
2622
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
Single test with Nasopharyngeal swab to detect SARS-CoV-2. Only 3 steps and a specific device (LoopDeeLab) to have a result.
Assay Type
Unknown
Self Test
No
Reader Required
Yes
Subcategory
Other ()
Method
LAMP
Measurement
Qualitative
Time
45 minutes
Positive control
co-amplification of actb gene
Analytical Sensitivity
95 %
Analytical Specificity
100 %
Clinical Sensitivity
95 %
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