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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Rapid COVID-19 Antigen Test(Colloidal Gold)

Manufactured by Anbio (Xiamen) Biotechnology Co., Ltd, China - www.anbio.com/ 

Device identification number
1822
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasal swab, Throat swab
Commercial Status
Commercialised
Last Update
2021-07-07 05:18:51 CET
Comments
1.This product was evaluated and approved by Paul-Ehrlich-Institute in Germany in Feb 2021. 2.This product was evaluated and approved by National Institutes for Food and Drug Control China in Dec 2020. 3.The LOD for this product was 425 TCID50/mL.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunoassay

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