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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Detection Kit for 2019-nCov nucleic acid (Fluorescence PCR)

Manufactured by Anlong Gene, China - www.anlongen.com/ 

Device identification number
33
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Reader Required
N.A.
Method
RT-PCR
LOD
200 copies/ml (200 copies/ml (ORF1ab gene) and 300 copies/ml (N gene))
Positive control
positive control, not specified
Negative control
Negative control not specified
Analitical Specificity
Not found
Throughput
Single tubes
Notes
fluorescence detection

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