COVID-19 In Vitro Diagnostic Medical Device - detail | COVID-19 In Vitro Diagnostic Devices and Test Methods Database

SARS-CoV-2 IgG/IgM Rapid Test Device

Manufactured by Zhuhai Encode Medical Engineering Co., Ltd, China - http://www.encode.com.cn/

Device identification number

985

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Near POC / POC

Target

Antibody, IgG, IgM

Commercial Status

Commercialised

Last Update

2021-05-10 01:18:20 CET

Assay Type

Immuno-Antibody

Rapid Diagnostic

Yes

Method

Immunoassay

Type of antigen

nucleocapsid

Evaluation of eleven rapid tests for detection of antibodies against SARS-CoV-2
Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid, antigen and antibody tests up to 22 August 2020
Point-of-care serological assays for delayed SARS-CoV-2 case identification among health-care workers in the UK: a prospective multicentre cohort study

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