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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

CoVard Covid-19 Nasal Antigen Test Kit

Manufactured by ARDİ MEDİKAL ARAŞTIRMA VE DİAGNOSTİK ÜRÜNLERİ SAN. TİC. LTD. ŞTİ., Turkey - www.ardimed.com 

Device identification number
3568
CE Marking
×No
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, 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), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 2, Respiratory Syncytial V (RSV), Rhinovirus
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold

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