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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-COV-2 VARIANTS REALTIME PCR KIT

Manufactured by Vircell s.l., Spain - www.vircell.com 

Device identification number
2084
CE Marking
×No
HSC common list (RAT)
×No
Format
Automated
Physical Support
Other (Vials)
Target type
Nucleic acid, RNA
Targets
nucleocapsid protein/gene, spike protein/gene
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Pathogens detected
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Other (Legionella pneumophila, Streptococcus pneumoniae, Streptococcus pyogenes, Candida albicans, Pseudomonas aeruginosa, Staphylococcus epidermis), Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Rhinovirus, SARS-CoV, SARS-CoV-2
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta)
Commercial Status
Commercialised
Last Update
2022-10-06 08:50:46 CET
Comments
N/A
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Self Test
No
Reader Required
Yes
Subcategory
Other (Diagnostic kit)
Method
RT-PCR
Measurement
Qualitative
Time
90 minutes
Subclass
Multiple
Detection Principle
Fluorescence

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements