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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 ELITe MGB® Kit

Manufactured by ELITechGroup, France - www.elitechgroup.com 

Device identification number
1861
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Fully automated (robot), Lab-based
Physical Support
Cartridge, Cassette, Microplate
Target type
Nucleic acid
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Endogenous Internal Control: RNase-P Available both Qualitative and Quantitative assay in association with SARS-CoV-2 ELITe Standard. Two available formats: 96 and 240 reactions. Validated in association to the S2R platform ELITe InGenius® and CFX-96 and ABI 7500 Fast Dx
Assay Type
Nucleic acid-PCR
Method
RT-PCR

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