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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Go Strips

Manufactured by Biomeme, United States - shop.biomeme.com 

Device identification number
91
CE Marking
×No
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Strip
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Notes
Positive percet agreement (PPA): 93.53; Negative percet agreement (NPA): 97.5; Total percet agreement (NPA): 95

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