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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

BD SARS-CoV-2/Flu for BD Max Systems

Manufactured by Becton Dickinson, United States - https://www.bd.com/en-us 

Device identification number
2883
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated
Target type
Nucleic acid
Targets
nucleocapsid protein/gene
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, 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
Information upon request
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Measurement
Qualitative

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