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

BIOSYNEX COVID-19 BSS

Manufactured by BIOSYNEX SWISS SA - https://www.biosynex.com/en/

Device identification number

779

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Lab-based

Target

Antibody

Specimen

Whole blood

Commercial Status

Commercialised

Last Update

03/26/2021 02:49

Assay Type

Immuno-Antibody

Rapid Diagnostic

Yes

Reader Required

Method

Immunoassay

Measurement

Qualitative

Time

10 minutes

Notes

Not found cassette Not found

Serologic responses to SARS-CoV-2 infection among hospital staff with mild disease in eastern France
Comparison of a rapid immunochromatographic test with a chemiluminescence immunoassay for detection of anti-SARS-CoV-2 IGM and IGG
Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid, antigen and antibody tests up to 22 August 2020

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