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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Quadruplex Real-Time PCR Detection Kit for SARS-CoV-2 ORF1ab/N and Influenza Viruses A/B

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

Device identification number
3057
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Lab-based, Manual
Target type
Nucleic acid
Targets
nucleocapsid protein/gene
Specimen
Oropharyngeal swab, Sputum
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B, SARS-CoV, Varicella Zoster Virus (VZV)
Pathogens detected
Influenza A, Influenza B
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