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

EIA COVID-19 RBD IgM

Manufactured by TestLine Clinical Diagnostics s.r.o., Czechia - www.testlinecd.com/

Device identification number

1138

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Automated, Manual

Target

Antibody, IgM

Specimen

Plasma, Serum

Commercial Status

Commercialised

Last Update

2021-05-10 01:04:00 CET

Comments

Pending patent issues

Assay Type

Immuno-Antibody

Reader Required

Yes

Subcategory

Sample preparation

Method

Immunoassay

Measurement

Qualitative

Time

90 minutes

Subclass

Fluorescence

Clinical Sensitivity

97.5 %

Performance of Severe Acute Respiratory Syndrome Coronavirus 2 Antibody Assays in Different Stages of Infection: Comparison of Commercial Enzyme-Linked Immunosorbent Assays and Rapid Tests

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