COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

3836

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Physical Support

Strip

Target type

Antigen

Antibody type

Monoclonal

Targets

nucleocapsid protein

Specimen

Anterior nasal swab

Cross-reactivity (pathogens tested)

Adenovirus, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Herpes Simplex (HSV), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza B, Influenza B Victoria, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B, Varicella Zoster Virus (VZV)

Pathogens detected

SARS-CoV

Lineages detected

B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma), P.3 (Theta)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Self Test

No

Reader Required

N.A.

Subcategory

N.A.

Method

Immunoassay

Measurement

Qualitative

Time

5 minutes

Subclass

Microfluidic

Detection Principle

Fluorescence