Theragen COVID-19 ASSAY
Manufactured by Theragen Genome Care, South Korea - https://www.eng.genomecare.net/
Device identification number
2165
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Physical Support
Microplate, Strip
Target
Nucleic acid
Specimen
Nasal swab, Throat swab
Pathogens detected
SARS-CoV
Lineages detected
A.23.1 (United Kingdom), B.1.1.7 (United Kingdom), B.1.351 (South Africa), B.1.526 (USA), B.1.526.1 (USA), B.1.526.2 (USA),
Commercial Status
Commercialised
Last Update
2021-08-03 10:11:45 CET
Comments
Real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Reader Required
Yes
Subcategory
Extraction kit
Method
RT-PCR
Measurement
Qualitative
Time
70 minutes
LOD
10 cpr
Positive control
The positive control is included in this product
Negative control
The negative control is included in this product
Analytical Sensitivity
100 %
Analitical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Notes
subclass: NIID_2019_nCOV_N
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