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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Multiplex Real-Time PCR Detection Kit for 17 Species of Respiratory Pathogens

Manufactured by Beijing Applied Biological Technologies Co. Ltd., China - https://www.x-abt.com/ 

Device identification number
3055
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Lab-based, Manual
Target type
Nucleic acid
Targets
nucleocapsid protein/gene
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
Bordetella Pertussis, Chlamydia Pneumoniae, Hemophilus Influenzae, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae
Pathogens detected
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV), Human Metapneumovirus (HMPV), Influenza A, Influenza B, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
/
Assay Type
Nucleic acid-PCR
Self Test
No
Reader Required
Yes
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