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

2019-nCoV IgM Antibody Determination Kit

Manufactured by Beijing Diagreat Biotechnologies Co., Ltd, China - www.diagreat.com/

Device identification number

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Near POC / POC

Target

Antibody, IgM

Specimen

Whole blood

Commercial Status

Commercialised

Last Update

2021-05-10 01:04:00 CET

Assay Type

Immuno-Antibody

Rapid Diagnostic

Yes

Reader Required

Yes

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

Subclass

Fluorescence

Crossreactivity

Reported

Clinical significance of IgM and IgG test for diagnosis of highly suspected COVID-19 infection
Diagnostic value of combined nucleic acid and antibody detection in suspected COVID-19 cases
Immunological assays for SARS-CoV-2: an analysis of available commercial tests to measure antigen and antibodies

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