COVID-19 In Vitro Diagnostic Medical Device - detail | COVID-19 In Vitro Diagnostic Devices and Test Methods Database

Multiplex Real-Time PCR Detection Kit for 27 Species of Respiratory Pathogens

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

Device identification number

3056

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, Sputum

Pathogens detected

Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza B, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus

Lineages detected

AT.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma),

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Assay Type

Nucleic acid-PCR

Self Test

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