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

2019-nCoV IgG/IgM Rapid Test Device

Manufactured by Safecare Biotech (Hangzhou) Co. Ltd, China - en.safecare.com.cn/

Device identification number

1035

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Near POC / POC

Physical Support

Lateral flow

Target

Antibody, IgG, IgM

Specimen

Whole blood

Commercial Status

Commercialised

Last Update

2021-05-10 01:04:00 CET

Assay Type

Immuno-Antibody

Rapid Diagnostic

Yes

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

Accuracy

90.2 %

Clinical Utility of a Highly Sensitive Lateral Flow Immunoassay as determined by Titer Analysis for the Detection of anti-SARS-CoV-2 Antibodies at the Point-of-Care

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