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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Loopamp SARS-CoV-2 Detection kit

Manufactured by Eiken Chemical Co. Ltd., Japan - www.eiken.co.jp 

Device identification number
1638
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
60 minutes
LOD
100 RNA-copies
Positive control
Positive Control 2019-nCoV (PC nCV19)
Throughput
48 tubes
Notes
https://www.eiken.co.jp/en/products/lamp/covid19test/

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