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

COVID-19 IgG/IgM Combo Rapid Test Device

Manufactured by Liming Bio-Products Co., Ltd - http://www.limingbio.com/

Device identification number

264

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Near POC / POC

Physical Support

N.A.

Target

Antibody

Specimen

Whole blood

Commercial Status

Commercialised

Last Update

03/18/2021 09:03

Assay Type

Immuno-Antibody

Rapid Diagnostic

Yes

Reader Required

Subcategory

N.A.

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

Subclass

Not found

LOD

Not Reported

Calibration

Not found

Crossreactivity

Not found

Not Reported

Precision

Not found

Accuracy

Not Reported

Reproducibility

Not Reported

Robustness

Not found

Clinical Sensitivity

IgG 82.2 (IgG); 64.7% (IgM)

Clinical Specificity

100 (IgG); 100 (IgM)

Notes

Rapid diagnostic test Strip Not found

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