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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 Nucleic Acid Test Kit

Manufactured by Assure Tech. (Hangzhou) Co., Ltd, China - www.diareagent.com 

Device identification number
1578
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Method
RT-PCR
Time
78 minutes
LOD
500 AU
Clinical Sensitivity
100 %
Notes
http://www.diareagent.com/product_list.html

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