COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

3019

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Microplate, Microtiter plate, Strip

Target type

Nucleic acid

Targets

envelope protein/gene, ORF1ab polyprotein/gene

Cross-reactivity (pathogens tested)

Adenovirus, Adenovirus 3, Adenovirus 7, Coronaviruses (HCoV), Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex (HSV), Human Immunodeficiency Virus (HIV), Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV), Rhinovirus

Pathogens detected

SARS-CoV

Lineages detected

A.23.1, AT.1, 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.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta),

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

http://www.easunbio.com/product/sars-coronavirussars-cov-real-time-rt-pcr-kit

Assay Type

Nucleic acid-PCR

Method

RT-PCR

Measurement

Quantitative

Detection Principle

Fluorescence

LOD

AU 200