COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

4144

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Other (See reagent kit)

Physical Support

Other (Vials)

Target type

Nucleic acid, RNA

Targets

angiotensin-converting enzyme 2, envelope protein/gene, membrane protein/gene, non-structural protein/gene NS10, non-structural protein/gene NS3a, non-structural protein/gene NS3b, non-structural protein/gene NS6, non-structural protein/gene NS7a, non-structural protein/gene NS9a, non-structural protein/gene Ns9b, non-structural protein/gene NSP1, non-structural protein/gene NSP10, non-structural protein/gene NSP12, non-structural protein/gene NSP13, non-structural protein/gene NSP14, non-structural protein/gene NSP15, non-structural protein/gene NSP16, non-structural protein/gene NSP2, non-structural protein/gene NSP3, non-structural protein/gene NSP4, non-structural protein/gene NSP5, non-structural protein/gene NSP6, non-structural protein/gene NSP7, non-structural protein/gene NSP8, non-structural protein/gene NSP9, Nonstructural protein/gene NS7b, nucleocapsid protein/gene, ORF1a polyprotein/gene, ORF1ab polyprotein/gene, ORF1b polyprotein/gene, spike protein/gene

Specimen

Other (Control)

Cross-reactivity (pathogens tested)

Other (N/A)

Pathogens detected

Influenza A H3N2, Influenza B, Respiratory Syncytial V (RSV) Type B, SARS-CoV-2

Lineages detected

Other (2019-nCoV)

Commercial Status

Commercialised

Last Update

2022-10-06 08:50:23 CET

Assay Type

Nucleic acid-PCR

Rapid Diagnostic

No

Self Test

No

Reader Required

Yes

Subcategory

Calibrant / control sample

Method

RT-PCR

Measurement

Quantitative

Subclass

Multiple

Detection Principle

Fluorescence