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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

1copy COVID-19 qPCR Kit

Manufactured by 1drop Inc, South Korea - www.1drop.co.kr/ 

Device identification number
1
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-09-16 10:00:56 CET
Comments
Based on KCDC method
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
200 copies/ml
Positive control
E gene plasmid and RdRp gene plasmid
Negative control
DEPC distilled water
Throughput
Single tubes
Notes
https://www.jenabioscience.com//files/jenabioscience/datasheet_extern/PCR-703.pdf

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