COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

3998

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Other (tube)

Target type

Nucleic acid

Targets

ORF1ab polyprotein/gene

Specimen

Nasopharyngeal swab, Oropharyngeal swab, Sputum

Cross-reactivity (pathogens tested)

Adenovirus 3, 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, Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Metapneumovirus (HMPV), MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus A, Rhinovirus B, Varicella Zoster Virus (VZV)

Pathogens detected

Influenza A, Influenza B, 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.1.617.1 (Kappa), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma),

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Assay Type

Nucleic acid-PCR

Rapid Diagnostic

No

Self Test

No

Reader Required

Yes

Subcategory

Validity test kit

Method

RT-PCR

Measurement

Qualitative

Time

51 minutes

Subclass

Multiple

Detection Principle

Other ()

LOD

500 copies/ml

Throughput

96 samples per run