COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

5786

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Other (tube)

Target type

Nucleic acid

Targets

nucleocapsid protein/gene, ORF1a polyprotein/gene, Other (RdRp gene)

Specimen

Nasopharyngeal swab, Other (Nasopharyngeal and Oropharyngeal swab), Sputum

Cross-reactivity (pathogens tested)

Beta Coronavirus HKU1 (HCoV-HKU1), Bordetella Pertussis, Hemophilus Influenzae, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Other (), SARS-CoV

Pathogens detected

Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Human Metapneumovirus (HMPV), Influenza A, Influenza B, Other (Rhinovirus C, Enterovirus, Bocavirus), Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus A, Rhinovirus B, SARS-CoV-2

Lineages detected

B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma),

Commercial Status

Commercialised

Last Update

2022-11-29 09:15:50 CET

Assay Type

Nucleic acid-PCR

Rapid Diagnostic

No

Self Test

No

Reader Required

N.A.

Subcategory

N.A.

Method

RT-PCR

Measurement

Qualitative

Time

110 minutes

Subclass

N.A.

Detection Principle

Fluorescence