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

Rapid Response COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)

Manufactured by BTNX Inc, Canada - www.btnx.com/

Device identification number

110

CE Marking

×No

HSC common list

×No

HSC mutual recognition

×No

Format

Near POC / POC

Physical Support

Cassette

Target

Antibody, IgG, IgM

Specimen

Plasma, Serum, Whole blood

Commercial Status

Commercialised

Last Update

2021-05-10 01:04:00 CET

Assay Type

Immuno-Antibody

Rapid Diagnostic

Yes

Method

Immunoassay

Notes

Rapid diagnostic test

Challenges in Laboratory Diagnosis of the Novel Coronavirus SARS-CoV-2
Immunological assays for SARS-CoV-2: an analysis of available commercial tests to measure antigen and antibodies
Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid, antigen and antibody tests up to 22 August 2020
Evaluation of six commercial mid to high volume antibody and six point of care lateral flow assays for detection of SARS-CoV-2 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