COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

3067

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Target type

Nucleic acid

Targets

ORF1ab polyprotein/gene

Cross-reactivity (pathogens tested)

Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, 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, 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.1.617.1 (Kappa), B.1.621 (Mu), 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

Other variants detected: Iota B.1.526; AZ.5; C.1.2; B.1.630; B.1.640: other pathogens checked for cross-reactivity: Adenovirus (type 1); Influenza A (H1N1pndm); Enterovirus (EV68); Legionella pneumophila; Streptococcus pneumoniae; Streptococcus pyogenes; Pneumocystis jirovecii (PJP); Candidia albicans; Pseudomonas aeruginosa; Staph. epidermidis; Strep. salivarius

Assay Type

Nucleic acid-Other