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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



Allplex SARS-CoV-2 Assay

Manufactured by Seegene, Inc., South Korea - https://www.seegene.com/ 

Device identification number
1128
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
multiplex real-time PCR assay to detect 4 target genes of SARS-CoV-2, specimens: Nasopharyngeal swab- Nasopharyngeal aspirate- Throat swab- Bronchoalveolar lavage- Sputum; Analytes:- N gene- S gene- RdRP gene- E gene - Internal Control (IC) ; No cross-reactivity confirmed with 54 respiratory pathogens including SARS, MERS and SARS-related viruses (distributed by ARROW DIAGNOSTICS SRL IT)
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Method
RT-PCR
Time
120 minutes
LOD
50 copies/reaction
Positive control
4 target genes: N gene; S gene; RdRP gene; E gene
Notes
http://www.arrowdiagnostics.it/download/microbiologia/infezionirespiratorie/BROCHURE_Allplex%20SARS-CoV-2.pdf

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