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

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

Manufactured by Hangzhou Biotest Biotech Co., Ltd - http://en.biotests.com.cn

Device identification number

212

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

N.A.

LOD

Not Reported

Calibration

Not Reported

Crossreactivity

Reported as not possible

Reported

Precision

Not Reported

Accuracy

Not found

Reproducibility

Not found

Robustness

Not Reported

Clinical Sensitivity

Not found

Clinical Specificity

Not found

Type of antigen

Notes

Rapid diagnostic test cassette

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