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 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)

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

Comments

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